1) Waco's BESTYETT Sandwiches Made Fresh Daily CHICKEN SALAD ON BREAD $2.25 Ingredients Homestyle Chicken Salad: Salad Dressing, Cooked Dark Chicken Meat, Celery, Cooked Chicken, Pickle Relish (Pickles, Water, Corn Syrup, Distilled Vinegar, Salt, Modified Food Starch, Sodium Benzoate [A Preservative], Alum, Spice, Natural Spice Flavors, FD&C Yellow #4, Polysorbate 80), Onions, Red Peppers, Water, Breadcrumbs, (Bleached Wheat Flour, Dextrose, Salt, Yeast), Salt, Soybean Oil, Modified Food Starch, Glucono-Delta Lactone, Spices, Chicken Base (Chicken Including Natural Chicken Juices, Salt, Chicken Fat, Sugar, Maltodextrin [From Corn], Hydrolyzed Vegetable Protein, Whey, Natural Flavorings, Yeast Extract, Turmeric), Xanthan Gum, Titanium Dioxide, Citric Acid. BREAD: Flour, Water, Corn Syrup, Nonfat Milk. Contains less than 2% of each of the following: Partially Hydrogenated Soy beal Oil, Salt, Yeast, Mono and Diglycerides, Calcium Steoroyl-2-Lactylate, Calcium Sulfate, Malted Barley, Calcium Propiate (To Retard Spoilage), Corn Starch Sodium Stearoyl-Lactylate, Ammonium Sulfate, Niacin, Calcium Peroxide, Iron, (Ferrous Sulfate), Potassium Bromate, Thiamine, Mononitrite, Riboflavin, Calcium Phosphate. Recall # F-1218-2011;

 

2) Waco's BESTYETT SANDWICHES Made Fresh Daily Pimento Cheese, Ingredients: Flour, Water, Corn Syrup, Nonfat Milk, Contains 2% or less of the following: Partially Hydrogenated Soybean Oil, Salt, Yeast, Mono and Diglycerides, Calcium Stearoyl-2-Lactylate, Calcium Sulfate, Malted Barley, Calcium Propionate (to retard spoilage), Corn Starch, Sodium Stearoyl-Lactylate, Ammonium Sulfate, Niacin, Calcium Peroxide, Iron, (Ferrous Sulfate), Potassium Biomate, Thiamine Mononitrate, Riboflavin, Calcium Phosphate, Pimento Cheese: Imitation Cheese (Whey, Partially Hydrogenated Soybean Oil, Sodium Caseinate, Cheese Cheddar, Swiss, and Colby (Milk, Cheese Culture, Salt, Enzymes). Water, Sodium Phosphate, Salt, Whey, Protein Concentrate, Skim Milk, Lactic Acid, Natural & Artificial Flavor, Sorbic Acid as a preservative, Milkfat, Sodium Citrate, Artificial Color). Salad Dressing, Pimentos, Red Peppers, Water, Dehydrated Cheese (Whey Cheddar Cheese (Milk, Cheese Cultures, Salt, Enzymes, Calcium Chloride], Salt, Disodium Phosphate, FD&C Yellow #5 and #6), Potassium Sorbate and Sodium Benzoate (as preservatives). Recall # F-1219-2011

None

Waco's Bestyett Sandwiches, Waco, TX, press release on April 8, 2011. FDA initiated recall is ongoing. 

The products contain undeclared eggs.

35 sandwiches

TX

CILANTRO in 1/2 lb and 1 lb. bulk bags --- The product is packaged in a sealed, clear plastic bag. Recall # F-1220-2011

Lot code: 6347 (product was packaged on 04/09/11 - Julian calendar date 99); Recall expansion: Lot code: 6361(Wash Date Julian code 110 which represents 04/20/2011)

Recalling Firm: Satur Farms LLC, Cutchogue, NY,  by press release and letter dated April 20, 2011 and Recall expansion: by press release and letters dated April 29, 2011.

Manufacturer: Satur Farms, Belle Glade, FL. FDA initiated recall is ongoing.

Product was found to be contaminated with Salmonella based on sampling and analysis by USDA and New York State Department of Agriculture & Markets. 

Lot 6347 - 138 lbs; Recall Expansion: Lot 6361- 88.5 lbs.

NY

Cucumbers, Plain, Raw. Raw cucumbers in white and green cardboard box with white, black and green lettering reads in part: front "***PRODUCT OF: USA***NATURE'S DELIGHT***FRUITS & VEGETABLES 1 1/9 Bu PRODUCT OF: USA. Recall # F-1221-2011

PL-RID-002990

Recalling Firm: L&M Companies, Inc., Raleigh, NC, by telephone and e-mail beginning April 21, 2011.

Manufacturers: Passline Farms, Labelle, FL

L&M Companies Inc., Immokalee, FL. FDA Initiated recall is ongoing.

FDA notified the firm that a sample of cucumbers tested positive for Salmonella. The affected cucumbers are beyond their shelf life.

1,590 cartons

NY, FL, IL, IN, MS, NE, TX and WY

1) Jonathan's Alfalfa Sprouts - 4 oz, 8 oz packaged in plastic clamshell. F-1236-2011;

 

2) Jonathan's Alfalfa with Radish Sprouts - 4 oz packaged in plastic clamshell. Recall # F-1237-2011;

 

3) Jonathan's Gourmet Sprouts - 4 oz packaged in plastic clamshell. Recall # F-1238-2011;

 

4) Jonathan's Alfalfa with Dill Sprouts - 4 oz packaged in plastic clamshell. Recall # F-1239-2011;

 

5) Jonathan's 4 oz Organic Alfalfa, packaged in plastic clamshell. Recall # F-1240-2011;

 

6) Jonathan's 4 oz Organic Alfalfa with Radish Sprouts, packaged in plastic clamshell. Recall # F-1241-2011;

 

7) Jonathan's Organic Sprout Salad 4 oz packaged in plastic clamshell. Recall # F-1242-2011;

 

8) Jonathan's 4 lb Bulk Alfalfa Sprout in 2 lb bags in a 13x9x6 cardboard carton and 5lb Bulk Alfalfa in waxed 18x11 cardboard cartons. Recall # F-1243-2011;

 

9) Jonathan's 5 lb Bulk Organic Alfalfa Sprouts in waxed 18 x 11 cardboard cartons. Recall # F-1244-2011

1) - 7) Sell-by dates 4/22 through 5/7

8) and 9) Code dates prior to 412

Jonathan's Sprouts Inc., Rochester, MA, by telephone, letter and press release on April 19, 2011 and April 22, 2011. Firm initiated recall is ongoing.  

Product contaminated with Salmonella.

10,340 lbs

CT, DE, MA, NH, VT, RI, ME, NY, MD, NJ, PA

Twist Tie Labeling for Cilantro Bunches (Publix only): "***CILANTRO #4889***PRODUCT OF USA***0 33383 80104 9***COOSEMANS WORLDWIDE***. Publix Case Labeling: "CILANTRO PUBLIX ITEM #24341 30 BUNCHES - (01) 45035377134044***PRODUCT OF USA." Chaney Brothers Box: "***FRESH HERBS***GARDEN FRESH HERBS***1 LB***CILANTRO***. C.H. Robinson Case Labeling - Tobacco Box:***PACKAGING: CS TT SLV ZIP*** Cilantro***PERISHABLE KEEP IN A COOLER***." C.H. Robinson Case Labeling - Rock Garden Box: "***rock garden***NET WT: 1 LB BAG 1 DOZEN 1 KILO BAG (35-40*F) - HERBES - (2-4*C) (50-60*F)-BASILS-(10-15*C) KEEP REFRIGERATED***" US Foodservice Case Labeling: "***rock garden***NET WT: 1 LB BAG 1 DOZEN 1 KILO BAG (35-40*F) - HERBES - (2-4*C) (50-60*F)-BASILS-(10-15*C) KEEP REFRIGERATED***" Jaycee Herb and China Cabinet - Tobacco Box: "*** From rock garden Fresh Cut Herbs***PACKAGING: CS TT SLV ZIP*** Cilantro***PERISHABLE KEEP IN A COOLER***." Recall # F-1245-2011

Lot # 58992

Herbs Unlimited Inc., Miami, FL, by telephone and letter beginning on April 28, 2011. FDA initiated recall is ongoing.

The product has the potential to be contaminated with Salmonella.

433 pieces

FL, Canada

1) Glenview Farms Mild Cheddar Feather Shred cheese: in cases of 4/5 lbs bags. Mild Cheddar feather shred (no label/Brand), 4 / 5 lb bags. Glenview Farms - Item number 99400, Manufacturing plant number 06-114; No label- item number  98615. Recall # F-1256-2011;

 

2) Cubed 1/2" mild cheddar in cases of 4/5 lbs bags, no label Item number 03001, Manufacturing plant number 06-114. Recall # F-1257-2011;

 

3) Block and Barrel Imperial Cheese Cubes Variety Pack; mild cheddar/Swiss/processed jack w/jalapeno pepper, 3/5 lb bags. Item number 98939, Manufacturing plant number 06-114. Recall # F-1258-2011;

 

4) Block and Barrel Imperial Cheese Cubes Variety Pack; mild cheddar/Swiss/Monterey jack w/jalapeno pepper, 3/5 lb bags. Item number 98940, lot code: 11035H, Manufacturing plant number 06-114. Recall # F-1259-2011;

 

5) Block and Barrel Imperial Cheese Cubes Variety Pack; mild cheddar/Colby Jack/Monterey jack w/jalapeno pepper, 3/5 lb bags. Item number 98941, Manufacturing plant number 06-114. Recall # F-1260-2011;  

 

6) California Select Farms, mild cheddar cheese cubes, 2 / 5 lb bags. Item number 02294, Manufacturing plant number 06-114. Recall # F-1261-2011;  

 

7) Cheswick brand Medium cheddar feather shred, 4/5 lb bags. Item number 02954, Manufacturing plant number 06-114. Recall # F-1262-2011;

 

8) James Farm Jack/cheddar feather shred, 4/5 lb bags. Item number 96990, Manufacturing plant number 06-114. Recall # F-1263-2011;

 

9) Parmesan, shaved, 2/5 lb bags Brand names of Arrezzi and Bellafo. Item number 02858, 2863S1, Manufacturing plant number 06-114. Recall # F-1264-2011

1) - 9) Lot code: 11035H

Pacific Cheese Co., Hayward, CA, by letter on February 18, 2011. Firm initiated recall is ongoing.

Firm found that through finished product testing that cheese contained L monocytogenes.

3,700 lbs

CA

1) Label on buckets: CKN Vanilla Whey, packaged in 7.5-lb. plastic buckets. Label in customer binders: CKN Nutrition Whey Advanced Vanilla, net wt. 7.5. lbs., containing whey concentrate, whey isolate, calcium caseinate, and egg white. Recall # F-1265-2011;

 

2) Label on buckets: CKN Chocolate Whey, packaged in 7.5-lb. plastic buckets. Label in customer binders: CKN Nutrition Whey Advanced Chocolate, net wt. 7.5. lbs., containing whey concentrate, whey isolate, calcium caseinate, and egg white. Recall # F-1266-2011

1) and 2) Lot # N2011027

Recalling Firm: The Shake Guy, LLC, Springfield, MO, by e-mails on February 14, 2011 and May 5, 2011.  

Manufacturers: The Shake Guy, LLC, Springfield, MO; Nellson Nutraceutical Inc., Irwindale, CA. Firm initiated recall is complete

The whey used in the manufacture of the finished products was potentially contaminated with Salmonella.

12/7.5-lb. buckets chocolate and 5/7.5-lb. buckets vanilla

KS, LA

The affected product is individually packaged in burgundy colored paperboard trays covered with clear plastic shrink wrap. The principal display panel on the side of the loaf reads in part: "Wolferman's***Cranberry Nut Natural and Artificial Flavor Tea Bread Net wt 11 oz. (311 g)". The product subject to recall are loaves that contain an incorrect ingredient statement that is intended for a different flavored tea bread. The ingredient label is on the bottom of the loaves. The CORRECT label reads in part: "***CRANBERRY NUT TEA BREAD***INGREDIENTS: Sugar, ***Walnut Pieces***CONTAINS WALNUTS, WHEAT, EGGS, MILK, SOY. ***Made for Wolferman's, A DBA of Harry and David, Medford, OR***". The INCORRECT label that was applied to some of the Cranberry Nut loaves reads in part: "CHERRY ALMOND TEA BREAD***INGREDIENTS: SUGAR, ***SLICED ALMONDS***CONTAINS WHEAT, EGGS, SOY, ALMONDS, MILK. Recall # F-1293-2011

Each loaf is labeled with a lot code of: "0321". 0 = the year of production (i.e. 2010) 321 = the julian date of production The ingredient panel of correctly labeled Cranberry Nut tea breads contains a bar code of "07147201760". The ingredient panel of Cherry Almond does NOT have a bar code. The products do not have an expiration or best-by date.

Recalling Firm: Wolferman's / Qvc, Medford, OR, by telephone and letters beginning May 6, 2011.

Manufacturer: Bernice's Foods Inc., Kansas City, KS. Firm initiated recall is ongoing.

Undeclared walnuts.

Approximately 729 loaves

Nationwide

Cross Valley Farms Grape tomatoes in 10 lb boxes. Recall # F-1299-2011

Lot: 0511521C

Recalling Firm: U.S. Foodservice - Sierra Div., Reno, NV, by telephone on May 9, 2011.

Manufacturer: Six L's Packing Company, Inc., Immokalee, FL. Firm initiated recall is ongoing.

Grape tomatoes distributed under the Cross Valley Farms brand name were provided by Six L and are under recall for salmonella.

14 x 10 lb boxes

CA, NV

1) Safeway's Eating Right Veggie Party Platter (Universal Product Code 79893-10708, weight 3 pounds, 6 ounces). Recall # F-1300-2011;

 

2) Mann's Veggies On the Go (Universal Product Code 16519 01411-6, weight 1 pound, 2 ounces). Recall # F-1301-2011;

 

3) Mann's Snacks on the Go with Celery, Carrots, Tomatoes (universal product code16519 01501-4, weight 8.75 ounces). Recall # F-1302-2011;

 

4) 1) Mann's Vegetable Platter Large (Universal Product Code 16519 01407-9, 2 pounds, 8 ounces); 2) Mann's Vegetable Platter Large (Universal Product Code 16519 01405-5, 3.5 pounds). Recall # F-1303-2011

1) Best if used by dates ranging from 05-09 to 05-16 2011;

2) Best if used by dates ranging from 05-09 to 05-16 2011;

3) Best if used by dates ranging from 05-09 to 05-16 2011;

4) 1) Best if used by dates ranging from 05-09 to 05-16 2011; 2) Best if used by dates ranging from 05-09 to 05-16 2011

Mann Packing Co Inc., Salinas, CA, by press release and letters on May 7, 2011. Firm initiated recall is ongoing. 

The grape tomatoes have the potential to be contaminated with salmonella. The firm received the product from a vendor who was supplied by Six L's Packing Company, Inc. of Immokalee, Florida.

1100 - 10 lb cases (11000 lbs)

Nationwide and Canada

1) Good Eats Chef Salad 8 ounce, Item# 60826766800034.Recall # F-1304-2011;

 

2) Good Eats Fresh Veggies and Ranch Snack Cup, 4.25 ounce, Item# 40826766801129. Recall # F-1305-2011;

 

3) Good Eats Side Garden Salad, 5 ounce, Item# 60826766800010. Recall # F-1306-2011;

 

4) Good Eats Mediterranean Mixed Greens, 7.5 ounce, Item# 60826766800058. Recall # F-1307-2011;

 

5) Good Eats Ovenable Southwest Medley, 5 ounce, Item# 20826766801552. Recall # F-1308-2011;

 

6) Walgreens Vegetable Garden Salad, 10.5 ounce, Item# 40049022542424. Recall # F-1309-2011;

 

7) Walgreens Greek Salad, 10.5 ounce; Item# 40049022542294. Recall # F-1310-2011;

 

8) Walgreens Mozzarella and Tomato Salad, 9 ounce, Item# 40049022556414. Recall # F-1311-2011;

 

9) Walgreens Veggie Tray with Ranch Dip, 5.25 ounce, Item# 40049022558678. Recall # F-1312-2011

1) Code date 5/7/11;

2) Code Date 5/7/11;

3) Code Date 5/7/11, Expire 5/6/11;

4) Code Date 5/7/11;

5) Code Date 5/7/11;

6) Code Date 5/7/11;

7) Code Date 5/7/11;

8) Code Date 5/7/11;

9) Expire 5/9/11

GH FOODS CA LLC, Sacramento, CA, by visit on May 2, 2011. Firm initiated recall is ongoing.

The grape tomatoes have the potential to be contaminated with salmonella. The firm received the product from a vendor who was supplied by Six L's Packing Company, Inc. of Immokalee, FL.

170 individual units

CA

1) Elsie Grace's Zippy Bacon Dip, packaged in .12-oz. plastic bags. Recall # F-1324-2011;

2) Elsie Grace's It's Smokin', packaged in .08-oz. plastic bags. Recall # F-1325-2011;

3) Elsie Grace's Cheesy Onion Dip, packaged in .08-oz. plastic bags. Recall # F-1326-2011;

4) Elsie Grace's Hearty Potato Soup Mix, packaged in 10.6-oz. paper bags. Recall # F-1327-2011;

5) Elsie Grace's Spuds & Cheese Soup, packaged in 10.6-oz. paper bags. Recall # F-1328-2011;

6) Elsie Grace's Broccoli Cheese Soup, packaged in paper bags (no net weight). Recall # F-1329-2011;

7) Elsie Grace's White Chili Soup Mix, packaged in 9.9-oz. paper bags. Recall # F-1330-2011

None

Elsie Grace's Gift Shoppe, Frankfort, KS, by press release on April 26, 2011 and by letters on April 29, 2011. FDA initiated recall is ongoing.

The product contains undeclared allergen (soy, milk, and wheat).

2,236 packages

Nationwide

Oberweis Dairy Super Premium Brownie Fudge Twirl Ice Cream (artificial flavor added); packed in One Quart (946 mL) round cardboard cartons; UPC 6 16029 06455 0. UPC 6 16029 06455 0. Recall # F-1331-2011

All dates

Oberweis Dairy, Inc., North Aurora, IL, by press release on May 10, 2011. Firm initiated recall is ongoing.

The brownie inclusion in the ice cream contains eggs which are not declared in the ingredients statement on the label.

3,989 quarts

IL, MO, IN, WI, MI, VA

Product is a chili powder blend packaged in sealable plastic bags in weights of 8oz, 1 lb, 5 lbs, 6 lbs, 8 lbs, and 10 lbs. Product labeled in part: "EPICUREAN ORGANICS CHILI POWDER***A blend of organic Red Pepper, organic Cumin seed, Sea Salt, organic Garlic, organic Oregano and Silicon Dioxide***Certified Organic***Lot#7215 Packaged and distributed by mountain rose herbs Eugene, OR 97405***Net Wt: 8 oz (227 gm) ***". The labels are the same for each size product except for the stated net weight (8 oz, 1 lb, etc.). Recall # F-1333-2011

Lot #7215

Mountain Rose Herbs, Eugene, OR, by telephone, e-mail, and letter beginning April 7, 2011. Firm initiated recall is ongoing.

Product may be contaminated with Salmonella.

Total of 229 pounds. (Number of bags by size: 8oz=38; 1lb=141; 5lb=7; 6lb=1; 8=1; 10lb=2)

Nationwide and Canada

Seasoned Cuttlefish: Net Wt. 15 lbs. Ingredients: Cuttlefish, vegetable oil, chili paste, sugar, malt syrup, sesame seeds, garlic, hon-dashi (salt, monosodium glutamate, lactose, sugar, dried bonito powder, yeast extract, disodum succinate). Recall #F-1334-2011

3/22/11 hand written on carton

Hnk Inc., Honolulu, HI, by telephone on March 28, 2011. Firm initiated recall is ongoing.

As part of HACCP plan firm conducted quarterly testing and found Listeria in their finished product.

11 cases, 5 cases of dried seasoned squid

HI

Vietnamese Cashew Nut Kernels Crop 2010, Product of Vietnam, Cashew LP, packaged in flex pack inside cardboard carton, 50 lbs. Raw. Recall #F-1335-2011

Units: USG70115, 34766

Recalling Firm: Specialty Commodities, Inc., Fargo, ND, by telephone and email on November 19, 2010 and by letter dated November 22, 2010.  

Manufacturer: Dakao Agricultural Produce Export And Production Co., Ltd, Ho Chi Minh City, Vietnam. Firm initiated recall is ongoing.

Cashew pieces have the potential to be contaminated with Salmonella.

28,050 lbs

CA, OR, TX

 

1) Mama Rose's Cilantro Con Queso, UPC Code: 7 90648 09020 3, 12 fl oz (340ml) jars. Recall # F-1228-2011;

 

2) Mama Rose's Hopi Corn Salsa sold as: Mama Rose's Hopi Corn Salsa, UPC Code: 7 906480 1070 6, 12oz jars; Fred Harvey Hopi Corn Salsa, UPC Code: 4 52030 16600 4, 12oz jars. Recall # F-1229-2011; 

 

3) Mama Rose's Garlic Con Queso, UPC Code: 7 906480 9010 4, 12 fl oz (340ml) jars. Recall # F-1230-2011;

 

4) Mama Rose's Viper Venom Con Queso, UPC Code: 7 90648 09000 5, 12 fl oz (340ml) jars. F-1231-2011

1), 3), and 4) All 6 digit Lots beginning with 260& & 270& Note: All Salsa with an expiration dates of 01/10/12 and earlier;

2) All 6 digit Lots beginning with 260& & 270& Note: All Salsa with an expiration dates of 01/06/13 and earlier;

Mama Rose's Gourmet Foods, Phoenix, AZ, by press release on January 20, 2011 and by letters on January 24, 2011. FDA initiated recall is ongoing.

The recall was initiated because the listed products have the potential to be contaminated with Clostridium botulinum.

150 cases

AZ, CO, WA

IQF vacuum packed 6 oz Ahi tuna steaks packed in a 10 lb master case. Producers-FDA Registration Number 19050729230 Product of Thailand no.1170 Wild Caught***PD.072310 YELLOWFIN TUNA STEAK 6 oz Net wt 10 lbs, Ingredients: Tuna***U.S. Patent No 5972401. Recall # F-1332-2011

Lot number: 269, Expiration date on cartons is: "EXP.072212"

Pacific Seafood Co., Inc., Clackamas, OR, by telephone on March 30, 2011. Firm initiated recall is complete.

Product may have elevated histamine levels.

710 lbs

AZ, CA, ID, OR, and WA. (primarily OR)

1) Garlic Paste, Ravi, Net Wt 32 oz. Recall # F-1233-2011;

2) Ginger Paste, Ravi, Net Wt 32 oz. Recall # F-1234-2011;

3) Garlic & Ginger Paste, Ravi, Net Wt 32 oz. Recall # F-1235-2011

1) Lot1020311;

2) Product shipped on 2/21/2011;

3) Lot #1010

Exotic Foodline LLC, Richardson, TX, by letter on March 15, 2011. FA initiated recall is ongoing.

Products may contain elevated PH ratios.

2,400 jars

TX

1) “Recaito Criollo Bohio” 6 oz, 12 oz and 32 oz - Cilantro-based seasoning. Recall # F-1249-2011;

2) "Sofrito Criollo Bohio" 6 oz, 12 oz and 32 oz Combination of aromatic herbal ingredients. Recall # F-1250-2011;

3) "Mr Special Sofrito" 12 oz Combination of aromatic herbal ingredients. Recall # F-1251-2011;

4) "Mr Special Recaito" 12 oz Cilantro-based seasoning. Recall # F-1252-2011

1) B26710, B26610, B27710, B27410, B28410, B29310, B29410, B30010, B30110, B30710, B32810, B34310, B34910, B34710, B36410, B02711, 03211, B03911, B06311, B07311, B08411, B32210, B35410, B04711, B26710, B21710, B28510, B28610, B30210, B32310, B34410, B02611, B03411, B27010, B27110, B27910, B31310, B33610, B35510, B04011, B06311, B32110, B35410, and B04711;

 

2) B24310, B27110, B27310, B28110, B31210, B33610, B35510, B03911, B04011, B06311, B26710, B26610, B27710, B27410, B28410, B29310, B29410, B30010, B30110, B30710, B32810, B34310, B34910, B34710, B36410, B02711, B03211, B03911, B06311, B07311, B08411, B32210 B35410 B04711;

 

3) B27210, B30810, and B31410;

 

4) B27210, B30910, and B31510

Bohio International Corp., Bayamon, PR, by letters on April 27, 2011. FDA initiated recall is ongoing.

Bohio International moved its operation to new facilities and did not register with FDA the location of the processing establishment nor the scheduled process for acidified foods. Hence, this results in the potential for bacterial growth, especially Clostridium botulinum.

175,270 units

PR and US Virgin Islands

1) Cobblestone Mill(R) 100% Whole Wheat Bread, 16 oz, UPC 0 72250 04171 3. Recall # F-1294-2011;

 

2) 100% Whole Wheat English Muffins sold under the following names: (1) Nature's Own(R) 100% Whole Wheat English Muffins, net wt. 12 oz (340g), UPC 0 72250 00376 3 (2) Sweetbay (TM) SUPERMARKET 100% Whole Wheat English Muffins, net wt. 12 oz (340g), UPC 0 99614 64218 8. Recall # F-1295-2011;

 

3) Honey Wheat English Muffins sold under the following brands: (1) Natural Grains(R) Honey Wheat English Muffins, net wt. 12 oz (340g), UPC 0 73105 92029 0 (2) Nature's Own(R) Honey Wheat English Muffins, net wt. 12 oz (340g), UPC 0 72250 00876 1. Recall # F-1296-2011;

 

4) Nature's Own(R) 100 Calorie Multi Grain English Muffins, net wt. 12 oz (340g), UPC 0 72250 00377 3. Recall # F-1297-2011

Best by dates: May 11 0355 119 and May 12 0355 120

Recalling Firm: Flowers Foods, Thomasville, GA, by visits, telephone, e-mail and press release on May 3, 2011.

Manufacturer: Flowers Bakery Of Montgomery LLC, Montgomery, AL. Firm initiated recall is ongoing.

Product may contain metal fragments.

60,180 units

Nationwide

1) Vegetarian Sausage, Breakfast Style, 16 oz. packages, UPC 054917981006. Recall # F-1313-2011;

 

2) Vegetarian Sausage, Chorizo, 16 oz. packages, UPC 054917988418. Recall # F-1314-2011;

 

3) Vegetarian Pat�, Wild Mushroom, 16 oz. packages, UPC 054917981051. Recall # F-1315-2011;

 

4) Tofu, Fine Herb, Organic, 16 oz. packages, UPC 754917901164. Recall # F-1316-2011;

 

5) Tofu, Italian Herb, Organic, 16 oz. packages, UPC 754917902161. Recall # F-1317-2011

 

6) Tofu, Spinach Jalapeno, Organic, Seasoned, 8 oz. packages, UPC 667262808081. Recall # F-1318-2011;

 

7) Tofu, Peanut & Ginger, Organic, Seasoned, 8 oz. packages, UPC 667262806087. Recall # F-1319-2011;

 

8) Tofu, Pesto, Organic, Seasoned, 8 oz. packages, UPC 667262801051. Recall # F-1320-2011;

 

9) Tofu, Spicy Thai, Organic, Seasoned, 8 oz. packages, UPC 667262871054. Recall # F-1321-2011;

 

10) Tofu, Indian Masala, Organic, Seasoned, 12 oz. packages, UPC 667262805080. Recall # F-1322-2011;

 

11) Tofu, Garlic Shiitake, Organic, Mushroom Seasoned, 12 oz. packages, UPC 667262800085. Recall # F-1323-2011

1) Use by date: 5/16/11;

2) Use by date: 5/16/11;

3) Use by date: 5/2/11;

4) Use by dates: 4/25/11, 5/16/11;

5) Use by date: 4/25/11;

6) Use by date: 6/16/11;

7) Use by date: 6/23/11;

8) Use by date: 6/23/11

9) Use by date: 6/2/11;

10) Use by date: 6/6/11;

11) Use by date: 5/9/11

Twin Oaks Community Foods, Inc., Louisa, VA, by e-mail and letter on March 24, 2011 and March 25, 2011. Firm initiated recall is ongoing.

Labels on the food do not specify the current name and place of business of the manufacturer.

372 units

VA, NC, GA, and FL

1) Amoxilina Capsules, 500mg, Dietary Supplement, UPC 619114010081. Recall # F-1336-2011;

 

2) Amoxilina Syrup, fl. oz., Dietary Supplement, Activates the immune system, UPC 619114010074. Recall # F-1337-2011;

 

3) Bisolbom, Broncheal Support Syrup, Adult, 4.06 fl. oz, Dietary Supplement, UPC: 619114010104. Recall # F-1338-2011;

 

4) Bisolbom, Broncheal Support Syrup, Child, 4.06 fl. oz, Dietary Supplement, UPC: 619114010198. Recall # F-1339-2011;

 

5) Neolubrina Fuerte, Syrup, Child, 3.38 fl. oz., Dietary Supplement, Effective against Fever and Pain, NDC 619114010234. Recall # F-1340-2011;

 

6) Neolubrina Fuerte, Tablets, 500 mg, Dietary Supplement, Effective against Fever and Pain, UPC: 619114010241. Recall # F-1341-2011;

 

7) Pentreximil Plus, Adult, 500 mg, 30 capsules, Activates the Immune System, UPC: 619114010012. Recall # F-1342-2011;

 

8) Pentreximil Plus, Adult, 3.4 fl. zo. (100 mL), Natural Antibiotic Qualities, UPC: 619114010050, Dietary Supplement. Recall # F-1343-2011;

 

9) Terramocina Capsules, 500 mg, Natural Qualities help with pain and stomach infection, Dietary Supplement, UPC: 619114010296. Recall # F-1344-2011;

 

10) Maxi-Vermex Tablets, 6 tablets, Natural treatment for intestinal parasite removal, Dietary Supplement, UPC: 619114010302. Recall # F-1345-2011;

 

11) Maxi-Vermex Tablets, 1 way, 1 tablet, Natural treatment for intestinal parasite removal, Dietary Supplement, UPC: 619114010326. Recall # F-1346-2011;

 

12) Maxi-Vermex, Syrup Bottle with 1 oz., Natural treatment for intestinal parasite removal, Dietary Supplement, UPC: 619114010319. Recall # F-1347-2011;

 

13) VitaA Derogil, Socucion Infantil (Child) en Gotas Auxiliar en la pervencion y tratamiento del la GRIPE (Helps in the prevention and treatment of COLDS), .50 oz (15ml), UPC #619114010142). Recall # F-1348-2011;

 

14) VitaA Derogil, Socucion Adulto (Adult), Auxiliar en la pervencion y tratamiento del la GRIPE (Helps in the prevention and treatment of COLDS), .50 oz (15ml), UPC #619114010159. Recall # F-1349-2011

None

Multimex, Tucker, GA, by press release on May 9, 2011 and by letter on May 11, 2011. FDA initiated recall is ongoing.

Label is false and misleading; Products are being promoted as antibiotics and make other medical claims.

Unknown

CA, CO, DE, GA, IN, IL, NC, TN and TX

 

 

Cool River sin azucar Bebida de Acerola 8 oz (Cool River without sugar Acerola Beverage 6% Juices). Recall # F-1222-2011

Lot 196 (Expires: 07/31/2011) & Lot 201 (Expires: 08/20/11)

San Mar Manufacturing Corp., Catano, PR, by letter on April 27, 2011. FDA initiated recall is ongoing

Lack of phenylketonurics warning statement (product contains aspartame) in product label.

1,062 units

PR

NutraSweet, Zero Calorie Sucralose Sweetener, Net Wt 0.035 oz. (1g). Recall # F-1298-2011

Lot numbers: Z0502C53, Z0513B53, Z0513C53, Z1041B53, and Z1041B63

American Sugar Refining, Dallas, TX, by letter on May, 10, 2011. Firm initiated recall is ongoing.

Incorrect product labeling declared Calcium Saccharin and Calcium Silicate, which are not ingredients in this product.

396 cases (2000 packets per case)

LA, CA, KS, and WI

 

Urinary Catheterization System, Rx only, Catalog Number: B6FB, B8FB, B10FB, B12FB, B14FB, B16FB, B18FB, B12CB, B14CB, B16CB, B12SB, B14SB, B12RB, B14RB, B16RB, B14FBK and B14FB-Female. Recall # D-531-2011

Lot numbers: 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0130, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0149, 0150, 0151, 0152, 0153, 0154, 0155, 0156, 0157, 0158, 0159, 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0168, 0169, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187, 0189, 0190, 0191, 0193, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1111, 1112, 1114, 1115, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 8127, 8128, 8129, 8130, 8131, 8132, 8133, 8134, 8135, 8136, 8137, 8138, 8139, 8140, 8141, 8142, 8143, 8144, 8145, 8146, 8147, 8148, 8149, 8150, 8151, 8152, 8153, 8154, 8155, 8156, 8157, 8158, 8160, 8161, 8162, 8163, 8164, 8165, 8166, 8167, 8168, 8169, 8170, 8171, 8172, 8173, 8174, 8175, 8176, 8177, 8178, 8179, 8180, 8181, 8182, 8183, 8184, 8185, 8186, 8187, 8188, 8189, 8190, 9101, 9102, 9103, 9104, 9105, 9106, 9107, 9108, 9109, 9110, 9111, 9112, 9113, 9114, 9115, 9116, 9117, 9118, 9119, 9120, 9121, 9122, 9123, 9124, 9125, 9126, 9127, 9128, 9129, 9130, 9131, 9132, 9133, 9134, 9135, 9136, 9137, 9138, 9139, 9141, 9142, 9143, 9144, 9145, 9146, 9147, 9148, 9149, 9150, 9151, 9152, 9153, 9154, 9155, 9156, 9157, 9158, 9159, 9160, 9161, 9162, 9163, 9164, 9165, 9166, 9167, 9168, 9170, 9171, 9172, 9173, 9174, 9175, 9176, 9177, 9178 and 9179

Recalling Firm: Apogee Medical, Inc., Youngsville, NC, by letter on April 13, 2011.  

Manufacturers: Apogee Medical, Inc., Youngsville, NC;  

H & P Industries, Inc., Hartland, WI. FDA initiated recall is ongoing.

CGMP Deviations: The Kits contain Povidone Iodine (PVP) Swabstick which are being recalled by H&R Industries due to failure to comply with FDA current cGMP regulations.

8.8 million kits

Nationwide

Perindopril Erbumine Tablets, 2 mg, 100-count tablets per bottle, Rx only; NDC 68180-235-01, UPC 3 68180 23501 9. Recall # D-529-2011

Lot #: 3100748, 3100747, 3100646, Exp 01/12; 3105582, Exp 11/12

Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD, by letter dated April 7, 2011. 

Manufacturer:Lupin Limited, Verna, Salcette, Goa, India. Firm initiated recall is ongoing.

 Subpotent (Single Ingredient) Drug: Product failed to meet assay results at the 12 month long term stability test point.

4,962 bottles

Nationwide

Sudafed 24 Hour (Pseudoephedrine HCl) 240 mg, Extended Release Tablets, Long-Acting Nasal Decongestant, 10 count blister, OTC; NDC: 50580-669-10. Recall #D-530-2011

Lot number: 1004651, Exp date: 2/14; Lot number: 1004652, Exp. date: 2/14; Lot number: 1005870, Exp. date: 3/14; Lot number: 1005874, Exp. date: 3/14; Lot number: 1008467, Exp. date: 6/14; Lot number: 1008468, Exp. date: 6/14; Lot number: 1009532, Exp. date: 6/14; Lot number: 1010850, Exp. date: 7/14; Lot number: 1013065, Exp. date: 7/14.

Recalling Firm: Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA, by letter on February 25, 2011.  

Manufacturer: Alza Corp., Vacaville, CA. Firm initiated recall is ongoing.

Labeling: Correct Labeled Product Miscart/Mispack: Typographical error on the carton display panel drug facts directions - the word "not" in the third line is repeated.

667,632 (10 tablets/carton)

Nationwide

 

1) Red Blood Cells Leukocytes Reduced. Recall # B-1304-11;

2) Cryoprecipitated AHF. Recall # B-1305-11

1) and 2) Units: W149508300555; W149510208917

Northern California Community Blood Bank, Eureka, CA, by email and facsimile on February 9, 2011. Firm initiated recall is complete.

Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.

4 units

Austria, CA

1) Red Blood Cells Leukocytes Reduced. Recall # B-1379-11;

2) Red Blood Cells. Recall # B-1380-11

1) Unit: T32817;

2) Units: T32027, T30812

Delta Blood Bank, Stockton, CA, by electronic mail on April 16, 2007. Firm initiated recall is complete.

Blood products, collected from donor who traveled to an area considered endemic for malaria, were distributed.

3 units

CA

Platelets Pheresis Leukocytes Reduced. Recall # B-1383-11

Units: FM52418 (part 1), FM52418 (part 2)

Sacramento Medical Foundation, Sacramento, CA, by telephone and facsimile on April 22, 2005. Firm initiated recall is complete.

Blood products, which were labeled as leukoreduced, but did not meet leukoreduction requirements, were distributed.

2 units

CA

Red Blood Cells Leukocytes Reduced. Recall # B-1384-11

Unit: V75193

Delta Blood Bank, Stockton, CA, by electronic mail on March May 22, 2007. Firm initiated recall is complete.

Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.

1 unit

CA

Red Blood Cells. Recall # B-1386-11

Unit: 1152034

Blood Bank of Hawaii, Honolulu, HI, by facsimile on August 1, 2007. Firm initiated recall is complete.

Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.

1 unit

CA, HI

1) Recovered Plasma. Recall #B-1402-11;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1403-11;

3) Fresh Frozen Plasma. Recall # B-1404-11

1) Unit: 6472310;

2) Units: 6472310; 6421722;

3) Unit: 6421772

South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on December 29, 2010. Firm initiated recall is complete.

Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

4 units

Austria, TX

Fresh Frozen Plasma. Recall # B-1406-11

Unit: W036511002726

LifeShare Blood Centers, Alexandria, LA, by facsimile on March 17, 2011. Firm initiated recall is complete.

Blood product, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), was distributed.

1 unit

LA

1) Red Blood Cells Leukocytes Reduced. Recall # B-1407-11;

2) Recovered Plasma. Recall # B-1408-11;

3) Platelets Pooled. B-1409-11

1) and 2) Unit: 22GJ31188;

3) Unit: 22LF22953

American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on February 24, 2011 and letter dated March 2, 2011. Firm initiated recall is complete.

Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.

3 units

PA, NJ, CA

Platelets Pheresis Leukocytes Reduced. Recall # B-1410-11

Unit: W280311900156

Upstate New York Transplant Services, Inc., Buffalo, NY, by telephone on March 8, 2011 and facsimile dated April 14, 2011. Firm initiated recall is complete.

 Blood product, labeled as leukoreduced, but which did not meet the requirements for leukoreduced product, was distributed.

1 unit

NY

1) Red Blood Cells. Recall # B-1427-11;

2) Cryoprecipitated AHF. Recall # B-1429-11

1) Units: W036810166779; W036810202443;

2) Unit: W036810166779

Community Blood Centers/S Florida Inc., Lauderhill, FL, by telephone on April 1, 2011 and by letter on April 4, 2011 and April 12, 2011. Firm initiated recall is complete.

Blood products, collected from a donor whose donor screening was incomplete, were distributed.

3 units

Switzerland, FL

1) Red Blood Cells. Recall # B-1438-11;

2) Fresh Frozen Plasma. Recall # B-1439-11;

3) Recovered Plasma. Recall # B-1440-11

1) and 2) Unit: W227710360214;

3) Unit: W227710392220

Mid-South Regional Blood Center, Memphis, TN, by facsimile on April 13, 2011. Firm initiated recall is complete.

Blood products, collected from a donor who was previously deferred for receiving a piercing, were distributed.

3 units

Switzerland, TN

Red Blood Cells Apheresis. Recall # B-1441-11 

Unit: W050911001629

HCSC-Blood Center, Bethlehem, PA, by telephone on April 13, 2011 and by letter dated April 16, 2011. Firm initiated recall is complete.

Blood product, which failed quality control testing for red cell volume, was distributed.

1 unit

PA

1) Red Blood Cells Leukocytes Reduced. Recall # B-1442-11;

2) Fresh Frozen Plasma. Recall # B-1443-11;

3) Platelets. Recall # B-1444-11

1), 2), and 3) Unit: W035211020862D

Carter BloodCare, Bedford, TX, by telephone on March 25, 2011 and May 3, 2011, by e-mail on April 18, 2011, and by letter dated April 18, 2011. Firm initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

3 units

NJ, TX

Source Plasma. Recall # B-1447-11

Unit: 0600118174

Biomat USA, Inc., Odessa, TX, by letter dated March 14, 2011. Firm initiated recall is complete.

Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.

1 unit

Spain

1) Recovered Plasma Recall # B-1448-11;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1449-11

1) and 2) Unit: 12GN37250

The American National Red Cross, Carolinas Region, Charlotte, NC, by letter on February 18, 2011. Firm initiated recall is complete.

Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of post donation information, were distributed.

2 units

GA, CA

 

Recovered Plasma. Recall # B-1306-11

Units: W149508300555; W149510208917

Northern California Community Blood Bank, Eureka, CA, by email and facsimile on February 9, 2011. Firm initiated recall is complete.

Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.

2 units

Austria, CA

Red Blood Cells Leukocytes Reduced. Recall # B-1382-11

Unit: 3699443

Central California Blood Center, Fresno, CA, by telephone and facsimile on September 26, 2006. Firm initiated recall is complete.

Blood product, collected from a donor who received an incomplete health history screening, was distributed.

1 unit

CA

Recovered Plasma. Recall # B-1387-11

Unit: 1152034

Blood Bank of Hawaii, Honolulu, HI, by facsimile on August 1, 2007. Firm initiated recall is complete.

Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.

1 unit

CA, HI

Recovered Plasma. Recall # B-1405-11

Unit: 12LP39077

Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by the LOGIC system on February 25, 2011 and March 25, 2007.

Manufacturer: American Red Cross Blood Services Carolinas Region, Winston Salem, NC. Firm initiated recall is complete.

Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.

1 unit

CA

Recovered Plasma. B-1428-11

Units: W036810166779; W03681020443

Community Blood Centers/S Florida Inc., Lauderhill, FL, by telephone on April 1, 2011 and by letter on April 4, 2011 and April 12, 2011. Firm initiated recall is complete.

Blood products, collected from a donor whose donor screening was incomplete, were distributed.

2 units

Switzerland, FL

Source Plasma. Recall # B-1450-11

Unit: 10FWIC4814

BioLife Plasma Services L.P., Fond Du Lac, WI, by electronically on April 7, 2011. Firm initiated recall is complete.

Blood product, which was collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, was distributed.

1 unit

Austria

Source Leukocytes. Recall # B-1445-11

Unit: W035211020862D

Carter BloodCare, Bedford, TX, by telephone on March 25, 2011 and May 3, 2011, by e-mail on April 18, 2011, and by letter dated April 18, 2011. Firm initiated recall is complete.

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

1 unit

NJ, TX

 

Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 or earlier. The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED. Recall # Z-2064-2011

S/No’s To obtain a complete list , refer to firm's website: Defibtech.com 101000001 101001000 101001001 101001002 101001003 101001004 101001005 101001006 101001007 101001008 101001009 101001010 101001011 101001012 101001013 101001014 101001015 101001016 101001017 101001018 101001019 101001020 101001021 101001022 101001023 101001024 101001025 101001026 101001028 101001029 101001030 101001031 101001032 101001033 101001034 101001035 101001036 101001037 101001038 101001039 101001040 101001041 101001042 101001043 101001044 101001045 101001046 101001047 101001048 101001049 101001052 101001053 101001055 101001056 101001058 101001059 101001060 101001061 101001062 101001063 101001064 101001065 101001066 101001067 101001068 101001069 101001070 101001071 101001072 101001073 101001074 101001075 101001076 101001077 101001078 101001079 101001080 101001081 101001082 101001083 101001084 101001085 101001086 101001087 101001088 101001089 101001090 101001091 101001092 101001095 101001096 101001097 101001098 101001099 101001100 101001101 101001102 101001104 101001105 101001106 101001107 101001108 101001109 101001110 101001111 101001112 101001113 101001114 101001115 101001116 101001117 101001118 101001119 101001120 101001121 101001122 101001123 101001124 101001125 101001126 101001127 101001128 101001129 101001130 101001131 101001132 101001133 101001134 101001135 101001136 101001138 101001139 101001140 101001141 101001142 101001143 101001144 101001145 101001146 101001147 101001148 101001149 101001150 101001151 101001152 101001153 101001154 101001155 101001156 101001157 101001158 101001161 101001162 101001163 101001164 101001165 101001166 101001167 101001168 101001169 101001170 101001171 101001172 101001173 101001174 101001175 101001176 101001177 101001178 101001179 101001181 101001182 101001183 101001184 101001185 101001186 101001187 101001188 101001189 101001190 101001191 101001192 101001194 101001195 101001196 101001197 101001198 101001199 101001200 101001201 101001203 101001204 101001205 101001206 101001207 101001208 101001210 101001211 101001212 101001213 101001214 101001215 101001216 101001217 101001218 101001219 101001220 101001221 101001222 101001223 101001224 101001225 101001226 101001227 101001228 101001229 101001230 101001231 101001232 101001233 101001234 101001235 101001236 101001237 101001238 101001239 101001240 101001241 101001242 101001243 101001244 101001245 101001246 101001247 101001248 101001249 101001250 101001251 101001252 101001253 101001254 101001255 101001256 101001257 101001258 101001259 101001260 101001262 101001264 101001265 101001282 101001283 101001284 101001285 101001286 101001287 101001288 101001289 101001290 101001291 101001295 101001309 101001311 101001312 101001328 101001344 101001345 101001346 101001347 101001348 101001349 101001350 101001351 101001352 101001354 101001355 101001356 101001357 101001358 101001359 101001360 101001374 101001379 101001380 101001381 101001382 101001383 101001385 101001386 101001387 101001388 101001390 101001391 101001392 101001393 101001394 101001395 101001396 101001397 101001398 101001401 101001403 101001405 101001407 101001408 101001409 101001411 101001412 101001414 101001415 101001417 101001420 101001421 101001423 101001424 101001425 101001426 101001427 101001428 101001430 101001431 101001432 101001433 101001434 101001435 101001436 101001437 101001438 101001439 101001440 101001441 101001443 101001444 101001445 101001447 101001448 101001449 101001450 101001451 101001452 101001453 101001454 101001455 101001457 101001458 101001459 101001460 101001461 101001463 101001464 101001466 101001467 101001468 10100

Defibtech, LLC, Guilford, CT, by letter dated March 11, 2011. Firm initiated recall is ongoing.

Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process.

91, 472 units

Nationwide and Internationally

 

Luxtec� MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure. Recall # Z-2060-2011

Serial numbers: 031009 0416410 035709 023210 102109 053510 126709 039810 0310710 0411210 057910 034910 065010 044110 064310 117209 602319 062010 022010 113009 090408 043510 117409 093108 051709 086908 118509 032510 057810 083109 043810 082708 030910 061408 054710 061310 084009 106509 053009 060110 412110 021709 033409 051109 072309 073708 080808 083408 084208 084808 092808 100808 104008 021809 071908 022609 070208 093208 103609 105609 105809 110309 110609 110709 110809 110909 111009 111109 111309 083208 090808 120308 010909 022709 075108 101209 104509 105109 106409 107809 108009 036509 122008 075208 010509 036009 061909 085209 073308 040309 031209 102309 062409 036709 122808 040709 121908 093608 101108 123308 051609 040909 010909 036209 127209 061509 106809 121808 040809 033910 036409 040209 103109 103708 121009 040909 034410 033710 122009 073809 113009 041160 076408 117409 060309 116709 075609 115009 117609 116309 074209 022309 043610 042710 032210 118709 035110 and 023410 057410 030710 116109 032310 073309 and 1110109

Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated March 8, 2011 and by telephone on March 9, 2011.
Manufacturers: Integra Radionics Inc., Burlington, MS;

Integra Luxtec, Inc., West Boylston, MA. Firm initiated recall is ongoing.

Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.

159 units

Nationwide, Canada, Australia, Germany, Netherlands, New Zealand, Norway, Singapore and Sweden

LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Electronic patient records management system. Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS 6.1 Complete 8147527 LANTIS 6.1 Essential 8147535 LANTIS 8.3 Complete 8147543 LANTIS 8.3 Essential 8147550 LANTIS 8.3 Commander 8148178. Recall # Z-2151-2011

None

Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 23, 2011.

Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is ongoing.

There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used.

47

Nationwide

The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber. Recall #Z-2199-2011

The manual contains the operating instructions for AS 104 Blood Cell Separator and has a Software Version 4.71.

Recalling Firm: Fresenius Kabi, LLC, Redmond, WA, by letter dated May 6, 2011.

Manufacturer: Fresenius Hemocare Netherlands B.V, Emmer-Compascuum, Netherlands. Firm initiated recall is ongoing.

Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011.

158 units

Nationwide

Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports. Recall # Z-2201-2011

APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2

Recalling Firm: Bio-Rad Laboratories, Redmond, WA, by letter dated July 19, 2010, via FedEx.

Manufacturer: Bio Rad Laboratories, Marnes La Coquette, France. Firm initiated recall is ongoing.

The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.

272 units

Nationwide

1) Brilliance iCT, Computed Tomography X-Ray System, including the Brilliance iCT SP system, Model Numbers: 728311 and 728306. The affected systems are equipped with the following software version: 3.2.0.19010. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-2205-2011;

 

2) Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-2206-2011;

 

3) Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subject to correction are equipped with software version: 3.5.17030. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-2207-2011

1) Serial Numbers: 100103, 100019, 100023, 100170, 200047, 200013, 200005, and 1000087;

2) Serial Numbers: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005, and 300010;

3) Serial Numbers: 7006, 7060, 7154, 7298, and 7349

Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on March 8, 2011. Firm initiated recall is ongoing.

A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.

23 system units

DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT

1) DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction. Recall # Z-2208-2011;

 

2) DePuy Mitek GRYPHON T BR Anchor w/ORTHOCORD� Product Code: 210812 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.Recall #Z-2209-2011;

 

3) DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD� Product Code: 210813 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction. Recall # Z-2210-2011;

 

4) DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD Product Code: 210814 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction. Recall # Z-2211-2011

1) Lot Numbers: 3403404 3411147 3415167 3415244 3417101 3418587;

 

2) Lot Numbers: 3409863 3415962 3416197 3416462;

 

3) Lot Numbers: 3449990 3451672 3452663 3453946 3455144 3455703 3456883 3462226 3468839 3473244 3476092 3476648 3477802 3478695 3479693 3484277 3486069 3477068 3494964 3495725;

 

4) Lot Numbers: 3450116 3452126 3452666 3453955 3455280 3455577 3456000 3456320 3457346 3459759 3462333 3463328 3463735 3464069 3473282 3474524 3476556 3478827 3478828 3478166 3496079 3495846

Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, by letter dated February 24, 2011.

Manufacturer: DePuy Mitek Sarl, Neuchatel, Switzerland. Firm initiated recall is ongoing.

Metal debris in the shaft component of the device.

10,822 units

Nationwide, and the countries of Australia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland

PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. Designed to be used only with the PercuNav" image guided intervention system. The Field Generator Stand (with articulating Mounting Arm) is used to position the Field Generator near the area of interest. Recall # Z-2219-2011

Serial Numbers: 03B8Y3, 20071000005, 20071000006, 20071000007, 20071000008, 20071000009, 20071000010, 20081000011, 20081000013, 20091000019, 20091000020, 20091000021, 20091000022, 20091000023, 02RCHF, 02X3NK, 034K1R, 039VDK, 039W1H, 03B4F3, 03B59R, 03B8MW, 03B8N0, 03B8QR, 03B8XX, 03B8XY, 03B8XZ, 03B8Y0, 03B8Y1, 03B8Y4, 03B8Y5, B0091T, B009BJ, B009HV, B009VJ, B00DDJ, B00DQ2, B00DQX, B00DQZ, B00DRF, B00DRP, B00DT7, B00DXM, B00DY0, B00F1Q, B00F3H, B00F3M, B00HKW, B00HKZ, B00HV4, B00HV7, B00HW3, B00HZR, B00J05, B00P3X, B00P3Y, B00P59, B00P5P, B00PB4, B00PJJ, B00PPP, B00PQ7, and P002A20090500005

Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 4, 2011. 

Manufacturer: Traxtal Technologies Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing

The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.

65 units (33 units distributed to US and 32 units distributed to other countries)

Nationwide, Australia, Austria, Belgium, China, France, Germany, Hong Kong, India, Korea, Netherlands, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom

Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical facilities, where the patient will be under the supervision of trained personnel. The Model SB dermatomes are used in skin banks for the harvesting of cadaver tissues. Universal Power Supply, Part Number DP0007 and DP0800 , used in the Integra Padgett Dermatome, Model S, Part Numbers 3539-700; and the Integra Padgett Dermatome, Model SB, Part Number 3539-800; and the Integra Padgett Dermatome, Model S6, Part Number: 3539-900. Recall # Z-2225-2011

Serial numbers: *S-11, S-137, S-152, S-173, S-186, S-214, S-231, S-243, S-245, S-254, S36, S-233, S-234, S-235, S917P, S-237, S-238, S-239, S444, S-242, S-244, S415, S-247, S-248, S-249, S-250, S-251, S353P, S-253, S-255, S-256, S-257,S-258, S-259, S-260, S-261, S-262, S-263, S-264, S-265, S-267, S-268, S-269, S-271, S-272, S-273, S-274, S-960, S-961, S-RP-220, S-RP-140, S-RP-182, S-RP-183, S759, S767, S315P, S659, S691, S697, S703,S704, S716, S728, S739, S342P, S412, SB004, SB008, SB021, SB031, SB042, SB043, SB044, SB045, SB050, SB051, SB052, SB073, SB074, SB075, SB076, SB082, SB083, SB088, SB089, SB090, SB091, SB092, SB093, SB094, SB095, SB100, SB102, SB103, SB104, SB107, SB108, SB109, SB111, SB112, SB113, SB114, SB115, SB116, SB117, SB126,SB127, SB130, SB131, SB132, SB133, SB134, SB135, SB136, SB137, SB138, SB139, SB140, SB141, SB142,SB143, SB144, SB145, SB146, SB147, SB148, SB149, SB168, SB169, SB170, SB171, SB172, SB173, SB176,SB177, SB178, SB179, SB180, SB185, SB190, SB192, SB193, SB194, SB195, SB196, SB197, SB198, SB199, SB200, SB204, SB206, SB208, SB210, SB211, SB216, SB221, SB222, SB229, SB231, SB232, SB233, SB237, SB241, SB242, SB243, SB244, SB254, SB256, SB257, SB258, SB259, SB260, SB261, SB262, SB263, SB264, SB265, SB266, SB267, SB268, SB269, SB270, SB271, SB272, SB273, SB274, SB275, SB276, SB291, SB304P, SB327, SB337, SB44, S857, S288, S436, S3856, S3886, S626, SRP220, S714, S715P, SB153, SB154, SB155, SB156, S612, S619, S620, S625, S684, N/A, N/A, SRP223(a), S496, S497, S509, S683, N/A, N/A, S341, S595, S610, S613, S618, S635, S637, S638, S680, S862, S865, S780, S764, S770, S773, S774, S916, S511P, S707,S782, S811, S358, S359, S3866, S456, S428, S520, S430, S431, S432, S529, S455, N/A, N/A, S506, S508, S686, S849, S927, SB249, SB250, SB251, SB252, SB253, SB255, S438, S439, S440, S481, S482, S484, S485, S486, S487, S542P, S596, S694, S696, S634, S495(a), S699, S718, S744, S745, S747, S519, S-538, S818, 5871, S291,S292, SRP228, S644, S645, S650, SB175, S391, S463, S453, S310, S348, S355, S368, S369, S370, S371, S372, S373, S374, S381, S382, S383, S384, S530, S654, SB006, SB038, SB105, SB125, SB128, SB129, SB150, SB151,SB152, SB157, SB158, SB159, SB160, SB161, SB162, SB163, SB164, SB165, SB166, SB167, SB174, SB181,SB182, SB183, SB184, SB186, SB187, SB188, SB189, SB191, SB201, SB202, SB203, SB205, SB207, SB223,SB224, SB227, SB228, SB278, SB279, SB280, SB281, SB286, SB297, SB331, SB332, SB88, SB039, S469, SB005, SB010, S679, S604, S760, S776, S594, S771, S473, S772, S785, S449, S435, S551, S817, S814, S779 S710, S719, S724, S727, S419, S709, 1/1/1989, N/A, N/A, SB123, S611, 1-582, S523, S524, S526, S527, S531, S532, S533, S582, S614, S295, S296, S362, S363, S577, S677, S387, S777, S778, S3936, S416, S417, S418, S390, S521, S539, S548, S583, S655, S669, S673, S495(b), S733, S546, S477, S514, S516, S517, S333, S681, S781,S839, S706, S424, S446, S660, S726, S361, S545, S682, S700, S717, SRP185, S330, S437, N/A, N/A, N/A, N/A, S276, S277, S278, S279, S280, S281, S282, S283, S284, S286, S287, S289, S290, S297, S298, S299, S305, S307,S308, S344, S345, S346, S347, S395, S396, S397, S398, S399, S400, S401, S402, S403, S404, S405, S406, S407,S408, S409, S410, S411, S420, S421, S422, SB016, SB017, SB018, SB023, SB024, SB025, SB026, SB027, SB028, SB032, SB033, SB034, SB035, SB036, SB037, SB040, SB041, SB046, SB047, SB049, SB053, SB054, SB055,SB056, SB057, SB058, SB059, SB060, SB061, SB062, SB063, SB064, SB066, SB067, SB068, SB069, SB071,SB072, SB077, SB078, SB079, SB080, SB081, SB084, SB085, SB086, SB087, SB106LC, SB118, SB119, SB120, SB121, SB122, SRP172, SRP173, SB289, SB290, SB324, SB328, SB329, SB330, SB2PC, SB007P, S312P, S736, S749, S752, S597, S598, S599, S4206, S816, S350, S351, S356, S357, S3816, S3876, S665, S675, S851, SRP229,S551, S605, S929, S608, S609, S648, S688, N/A, N/A, N/A, N/A, N/A, N/A, S450, S758, S906, S554, S678, S559, S713, S603, N/A, N/A, N/A, N/A, S513, S788, S789, S306, S4006P, N/A, N/A, SRP211, S322, S323, S457, S458, S319P, S300, S850, S689, S560, S561, S563, S568, S570, S572, S343, S429, S580, S337, S3966, S4016, S4056P,S666PZ, SB282, SB283, SB284, SB285, SB287, SB288, S507, SB065, SB070, SB097, SB098, S366, S367, SB013,SB015, S565, SRP222, S4196, S812, 5587, 5588, 5589, S587, S589, N/A, N/A, S914, S492, S685, S493, S364,S365P, SB012, SB014, SB225, SB226, SB230, SB240, SB277, S502, N/A, N/A, S540, S541, S692, S693, S695, S555, S556, S649, S768, S783, SRP184, SRP186, S483, S720, S543, S544, S336, S360, S905, S314P, S317P,S3836, S3846P, S392, S393, S394P, S4036P, S413, S414, S479, S490, S491, S501, S510, S549, S746P, S748P,SB099, SB101, SB234P, SB235P, SB236, SB245P, SB246, SB247, SB248, SRP243, S459, S3976, S601, S602,S454, S331, SRP242, S926, S925, S633, S629, S550, S488, S489, N/A, N/A, S896, S895, S890, S302, S301, N/A, N/A, SRP231, S293, S923, S349, S750, S442, S441, SRP244, S607, S443, S586, 5586, S309, S584, S576, S471, S910, S687, S536, SRP233, SRP232, S3826, S385, S294P, S784, S753, S751, S722, S721, S711, S708, S705, S698,S579, S578, S575, S574, S573, S567, S558, S557, S329, S328, S327, S326, S325, S324, S389, S690, S663, S661, S335, S334, S332, SB239P, SB238, S730P, S729P, S725, S285, SB124, SB110, S647, S464, S448, S434, S909,S853, S847, S731, S475, S474, S472, S4136, SRP227, SRP221, S339, S466, S908, SRP188, SRP187, SB326, SB325, SB323, SB296, SB295, SB294P, SB293, SB292, SB220, SB219, SB218, SB217, SB215, SB214, SB213, SB212, SB209, S476, S468, S467, S4026P, S3916P, S3906L, S503, S754, S848, S641, S636, SRP201, SRP200, SRP199, SRP198, SRP197, SRP196, SRP195, SRP194, S623, S621, SRP230, S674, S667, S547, S919, S918, S632, S631, S630, S628, S737, S622, S352, S3986, S3926, SRP223(c), N/A, N/A, S735, S593, S592, S591, S590, S581, S500, S499P, S740, S852, S734, S732, and S892. *All Dermatome Power Supply units distributed from 3/2/2005 through 4/19/2010 are subject to recall/replacement. According to the firm, certain of the suspect units distributed had no identifiable serial numbers but recall letters were sent to the customers of these units. The firm chose to identify these units as: N/A for the sake of counting the serial numbers of the affected product.

Recalling Firm: Integra LifeSciences Corp. Plainsboro, NJ, by telephone on March 10, 2011 and letters on March 11, 2011, March 14, 2011 and on April 12, 2011.

Manufacturer: Integra LifeSciences Corp., Cincinnati, OH. Firm initiated recall is ongoing.

Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient.

1,047 units

Nationwide and Canada

Unicel� DxH 800 Coulter� Cellular Analysis System. A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Part # 629029. Recall # Z-2227-2011

None

Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on April 12, 2011.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

The recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old.

673 units total (314 in US)

Nationwide, Canada, Australia, Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom

Stryker, Impression, Non-Powered Mattress, Model 2980. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress. Recall # Z-2240-2011

09AC000234, 09AC000235, 09AC000236, 09AC000237, 09AC000238, 09AC000239, 09AC000240, 09AC000241, 09AC000242, 09AC000243, 09AC000244, 09AC000245, 09AC000246, 09AC000247, 09AC000248, 09EA000807, 09EA000808, 09EA000809, 09EA000810, 09EA000811, 09EA000812, 09EA00081, 09EA000814, 09EA000815, 09EA000816, 09EA000817, 09EA000818, 09EA000819, 09EA000820, 09EA000821, 09EA000822, 09EA000823, 09EA000824, 09EA000825, 09EA000826, 09EA000827, 09EA000828, 09EA000829, 09EA000830, 09EA000831, 09FA000833, 09FA000834, 09FA000835, 09FA000836, 09FA000837, 09FA000838, 09FA000839, 09FA000840, 09FA000841, 09FA000842, 09FA000843, 09FA000844, 09FA000845, 09FA000846, 09FA000847, 09FA000848, 09FA000849, 09FA000850, 09FA000851, 09FA000852, 09FA000853, 09FA000854, 09FA000855, 09FA000856, 09FA000857, 09FA000858, 09FA000859, 09FA000860, 09FA000861, 09FA000862, 09FA000863, 09FA000864, 09FA000865, 09FA000866, 09FA000867, 09FA000868, 09FA000869, 09FA000870, 09FA000871, 09FA000872, 09FA000898, 09FA000899, 09FA000900, 09FA000901, 09FA000902, 09FA000903, 09GA000920, 09GA000921, 09GA000922, 09GA000923, 09GA000924, 09GA000925, 09GA000926, 09GA000927, 09GA000928, 09JA001517, 09JA001518, 09JA001519, 09JA001520, 09JA001521, 09JA001522, 09JA001523, 09JA001524, 09JA001561, 09JA001562, 09JA001563, 09JA001564, 09JA001565, 09JA001566, 09JA001567, 09JA001568, 09JA001569, 09JA001570, 09JA001571, 09JA001572, 09JA001573, 09JA001574, 09JA001575, 09JA001576, 09JA001577, 09JA001578, 09JA001579, 09JA001580, 09JA001581, 09JA001582, 09JA001583, 09JA001584, 09JA001585, 09JA001586, 09JA001587, 09JA001588, 09JA001589, 09JA001590, 09JA001591, 09JA001592, 09JA001593, 09JA001594, 09JA001595, 09JA001596, 09JA001597, 09JA001699, 09JA001700, 09JA001701, 09JA001702, 09JA001703, 09JA001704, 09KA002025, 09KA002026, 09KA002064, 09KA002065, 09KA002066, 09KA002067, 09KA002068, 09KA002069, 09KA002070, 09KA002071, 09KA002072, 09KA002073, 09KA002074, 09KA002075, 09KA002076, 09FA000896, 09FA000897, 09AC000249, 09AC000250, 09AC000251, 09AC000252, 09AC000253, 09DA000598, 09DA000599, 09EA000832, 09HA0001046, 09HA0001047, 09HA0001048, 09HA0001049, 09HA0001050, 09HA0001051, 09HA0001052, 09HA0001053, 09HA0001054, 09HA0001055, 09HA0001056, 09HA0001057, 09HA0001058, 09HA0001059, 09HA0001060, 09HA0001061, 09HA0001062, 09HA0001063, 09HA0001064, 09HA0001065, 09HA0001066, 09HA0001067, 09HA0001068, 09HA0001069, 09HA0001070, 09HA0001071, 09HA0001072, 09HA0001073, 09HA0001074, 09HA0001075, 09HA0001076, 09HA0001077, 09HA0001078, 09HA0001079, 09HA0001080, 09JA001698, 09JA001705, 09JA001706, 09JA001707, 09JA001708, 09HA001292 and 09HA001305

Recalling Firm: Stryker Medical Division of Stryker Corp., Portage, MI, by letter dated April 29, 2011.  

Manufacturer: Flextronics Ems Ca, L'isletville, Canada. Firm initiated recall is ongoing.

Affected mattresses may not conform to federal flammability standards.

213 units

Nationwide and Canada

syngo Dynamics version 9.0. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images. Recall # Z-2293-2011

Units: 10091602, 10091604

Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by letter dated March 24, 2011. Firm initiated recall is ongoing.

If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed.

29 units

CA, CT, FL, ID, MD, MI, MN, NJ, NY, PA

Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11. The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The E Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The E Series may be used for the monitoring a patients electrocardiogram (ECG). Recall # Z-2294-2011

Serial Numbers: AB05D000033 AB05F000398 AB05F000405 AB05F000425 AB05F000426 AB05F000430 AB05F000437 AB05F000446 AB05F000448 AB05F000450 AB05F000451 AB05F000456 AB05F000463 AB05F000465 AB05F000466 AB05F000468 AB05F000469 AB05F000470 AB05F000471 AB05F000474 AB05F000482 AB05F000483 AB05F000484 AB05F000485 AB05F000511 AB05F000512 AB05I000666 AB05I000668 AB05I000669 AB05I000670 AB05I000673 AB05I000675 AB05L000906 AB05L000909 AB05L000911 AB05L000920 AB05L000943 AB05L000944 AB05L000945 AB06A000960 AB06A000961 AB06A000964 AB06A000966 AB06A000974 AB06A000987 AB06A000989 AB06A000990 AB06A000994 AB06B001071 AB06B001091 AB06B001093 AB06B001094 AB06B001096 AB06B001110 AB06B001124 AB06B001163 AB06B001181 AB06C001211 AB06C001267 AB06C001275 AB06C001276 AB06C001277 AB06C001336 AB06C001337 AB06C001338 AB06C001339 AB06C001343 AB06C001344 AB06C001346 AB06C001364 AB06D001422 AB06D001431 AB06D001434 AB06D001437 AB06D001439 AB06D001442 AB06D001450 AB06D001582 AB06E001647 AB06E001649 AB06E001650 AB06E001653 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ZOLL Medical Corp., Chelmsford, MA, by letter dated April 22, 2011. Firm initiated recall is ongoing.

Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy.

874 units

Nationwide and countries of: Australia, Canada, Finland, Germany, Malaysia and United Kingdom