Recalls, Withdrawals, Field Corrections & Notifications

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Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

Market Withdrawals are a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA, or which involves no violation.

The most recent action is added to the top of the list. Dates refer to the effective date of the recall, withdrawal, correction, or notification.

Recalls older than 5 years have been archived and can be obtained by placing a Freedom of Information (FOI) Request.


2008

Important Notification: Red Cell Collection Kits - Haemonetics Corporation - 9/8/2008

Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] - Genzyme Corporation - 8/22/2008

Recall: Antihemophilic Factor, Human - CSL Behring L.L.C. - 8/18/2008

Medical Device Notification (PSN-08-06) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. - 8/15/2008

Medical Device Notification (PSN-08-08) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. - 7/28/2008

Recall of m2000sp Instrument - Abbott Molecular - 6/30/2008

Medical Device Notification (PSN-08-05) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. - 6/24/2008

Correction of AUSZYME Monoclonal Assay - Abbott Laboratories - 6/12/2008

Urgent Product Correction - Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test - Bio-Rad Laboratories - 6/6/2008

Medical Device Notification (PSN-08-03) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. - 6/5/2008

Medical Device Recall: BioArchive (Vapor Bypass Assembly) - Thermogenesis Corporation - 5/7/2008

Withdrawal of Albumin (Human) 5% - Talecris Biotherapeutics - 4/30/2008

Product Correction: Hepatitis B Surface Antigen AUSAB EIA - Abbott Laboratories - 4/21/2008

Important Product Correction Notification: Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests - Ortho Clinical Diagnostics, Inc - 4/21/2008

Recall of Rho(D) Immune Globulin (Human); Hyper RHO S/D, Mini-Dose - Talecris Biotherapeutics, Inc - 4/18/2008

Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] - Genzyme Corporation - 4/9/2008

Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc - 3/26/2008

Medical Device Notification: Filtered Red Cell Disposable Kits - Haemonetics Corporation - 2/26/2008

Recall of ThermoGenesis AXP Bag Sets 8-5101 - ThermoGenesis Corporation - 2/19/2008

Recall of Uni-Gold Recombigen HIV - Trinity Biotech USA - 2/12/2008

Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. - 2/11/2008

Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] - Genzyme Corporation - 2/11/2008

Recall of Hymenoptera (Honey Bee) Venom Products - Hollister-Stier Laboratories - 1/29/2008

Recall of Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2 - Sunquest Information Systems, Inc. - 1/23/2008

Recall of White-Faced Hornet Venom Protein - Hollister Stier Laboratories LLC - 1/7/2008


2007

Market Withdrawal of Octagam - Octapharma USA Inc. - 12/24/2007

Medical Device Notification: Sunquest Laboratory Blood Bank Module - Sunquest Information Systems, Inc. - 12/14/2007

Recall of PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] - Merck & Co., Inc. - 12/11/2007

Recall of Tubing Sets used with COBE Spectra Apheresis System, Trima and Trima Accel Automated Blood Collection Systems - Gambro BCT, Inc. - 11/26/2007

Important Notification: Blood Grouping Reagent Anti-Lea BioClone 2.0 - Ortho Clinical Diagnostics, Inc. (OCD)- 10/30/2007

Recall of CROFAB (Crotalidae Polyvalent Immune Fab (Ovine) - Protherics - 10/29/2007

Medical Device Notification: Data Innovations Instrument Manager - Data Innovations, Inc. - 9/19/2007

Medical Device Notification: TERUFLEX CPDA-1 Blood Bag System - Terumo Medical Corporation - 8/1/2007

Field Correction of Transfer Sets Packed with Humate-P - CSL Behring LLC - 7/24/2007

Recall of Level 1 Normothermic IV Fluid Administration and Irrigation Sets - Smiths Medical ASD, Inc. - 7/23/2007

Recall of CS3000 Apheresis Kits - Fenwal, Inc. - 6/21/2007

Recall of m2000sp and m1000 Instrument - TECAN Schweiz AG / Abbott Molecular, Inc. - 6/12/2007

Recall of Bean, String Green Allergenic Extract - Alk Abello - 4/13/2007

Market Withdrawal of LAL Reagent - Associate of Cape Cod - 3/9/2007

Recall of Medical Devices - Biomet Biologics, Inc - 3/5/2007

Important Notification: Fast Flow Fluid Warmers - Smiths Medical - 2/22/2007

Biological Product Withdrawal of Carimune NF Immune Globulin Intravenous - ZLB Behring - 2/21/2007

Recall of FETALSCREEN - Ortho-Clinical Diagnostics - 1/9/2007


2006

Notification of BacT/VIEW C.30a Software Update - bioMerieux, Inc - 12/20/2006

Notification of BacT/VIEW Software (all versions) - bioMerieux, Inc - 12/19/2006

Recall of Vironostika HIV-1 Microelisa System - bioMerieux, Inc - 12/18/2006

Recall of Dupaco Blood/Fluid Warming Set - (Dupaco, Inc.) - 10/11/2006

Recovery Notice - Fluvirin (Influenza Virus Vaccine) - (Novartis Vaccines and Diagnostics Limited / Cardinal Health Care) - 10/20/2006

Recall of Home Access and Home Access Express HIV-1 Test System - (Home Access Health Corporation) - 10/6/2006

Field Action Notification - Becton Dickinson (BD) Procount Kit - (BD Biosciences) - 8/10/2006

Important Drug Information - Antihemophilic Factor (Human), Koate DVI - (Talecris Biotherapeutics) - 7/24/2006

Important Drug Information - Antihemophilic Factor (Human), Koate DVI (3 lots) - (Talecris Biotherapeutics) - 7/24/2006

Recall of RAD-SURE Blood Irradiation Indicators - (International Specialty Products / Kent Adhesive Products Company) - 7/21/2006

Important Customer Notification - Vironostika HIV-1 - (bioMerieux, Inc) - 7/20/2006

Recall of BD CMVScan Card Test Kit - (Becton Dickinson Diagnostics) - 6/20/2006

Recall of Decavac Vaccine - (Amerisource Bergen / Sanofi Pasteur, Inc.) - 5/30/2006

Medical Device Recall - Ranger High Flow Blood / Fluid Warming Disposable Sets - (Biotest Laboratories, Inc. / Arizant, Inc.) - 4/26/20006

Field Correction: Galileo Blood Bank Analyzer - (Immucor, Inc) - 3/30/2006

Medical Device Notification - Misys Laboratory Blood Bank Module, Version 6.1 - (Misys Healthcare Systems) - 3/15/2006

Recall of Allergenic Extracts - (Greer Laboratories) - 3/9/2006

Field Correction - Medi-Temp III, Blood and Fluid Warmer - (Gaymar Industries, Inc.) - 2/14/2006

Device Correction: Operator's Manual for Baxter Fenwal Amicus Separator - (Baxter Healthcare Corp) - 1/25/2006


2005

Notice of Field Correction: Haemonetics MCS+ 9000, Cell Saver 5, Cell Saver 5+ - (Haemonetics Corp) - 12/15/2005

Recall of Charter Medical Transfer Bags - (Charter Medical, Ltd) - 11/21/2005

Recall of LCG2 Leukoreduction System for Red Blood Cells - (MacoProductions S.A.S.) - 11/18/2005

Recall of Baxter ALYX Red Kit Disposables - (Baxter Healthcare Corp) - 10/28/2005

FDA Provides Information on Investigation into Human Tissue for Transplantation - 10/26/2005

Recall of Human Tissue Products - (Regeneration Technologies, Inc) - 10/14/2005

Recall of Human Tissue - (Biomedical Tissue Services, Ltd) - 10/13/2005

Medical Device Notification: Transfer Set with 150 Micron Filter - (Charter Medical, Ltd) - 10/13/2005

Recall of Human Tissue Products - (Tutogen Medical, Inc) - 10/12/2005

Recall of Human Tissue Products - (The Blood and Tissue Center of Central Texas) - 10/11/2005

Recall of Plasma Protein Fraction, Plasmanate - (Talecris Biotherapeutics) - 10/11/2005

Withdrawal of Human Tissue Products - (Lost Mountain Tissue Bank) - 10/10/2005

Recall of Human Tissue Products - (LifeCell Corp) - 9/30/2005

Recall of Albumin (Human) 25%, Albuminar - (ZLB Behring LLC) - 8/26/2005 - Updated information

Recall of Albumin (Human) 25%, Albuminar - (ZLB Behring LLC) - 8/29/2005

Medical Device Notification: Hotline L-10 Gas Vent - (Smiths Medical ASD, Inc) - 8/2/2005

Recall of Level 1 H-31B Air Detector / Clamping Devices and Level 1 H-1200 Fast Flow Fluid Warmers - (Smiths Medical ASD, Inc) - 6/20/2005

Recall of Hemoflow Model 300 - (Applied Science, Inc) - 6/14/2005

Medical Device Notification: 150mL Eight Bag Aliquot System with Piercing Pin and Needleless Syringe Adaptor - (Charter Medical, Ltd.) - 6/10/2005

Medical Device Notification: Misys Laboratory Blood Bank and Blood Donor, Version 6.1 - (Misys Healthcare System) - 5/20/2005

Urgent Product Correction: Six-Part BarCode Labels for Sarstedt Tubes - (Roche Diagnostics Corporation, Inc.) - 5/17/2005

Recall of Platelet Sampling Device - (Charter Medical, Ltd) - 3/30/2005

Recall of CPDA-1 Quadruple Blood-Pack Unit, Baxter Blood-Pack Unit (BPU) with Samplink Access Device - (Baxter Healthcare Corp) - 3/16/2005

Device Correction of Baxter Amicus Separator - (Baxter Healthcare Corp) - 3/16/2005

Recall of Sepacell PLS-5A Platelet Leukoreduction Filter with Administration Set, Platelet Bedside Filter - (Baxter Healthcare Corp) - 3/15/2005

Medical Device Notification: HNA Classic 306 Patient Manager Blood Bank Software - (Cerner Corp) - 2/25/2005

Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection System - (Haemonetics Corp) - 2/25/2005

Medical Device Notification: StemCXP Software, Version 1.0 - (Beckman Coulter, Inc) - 2/24/2005

Recall of Additional Lot of Leukocyte Reduction BPF4 High Efficiency Filter - (Pall Medical Corp) - 2/23/2005

Notice of Field Correction: Sorvall Cellwasher 2, Cell Washing System - (Kendro Laboratory Products) - 2/18/2005

Important Product Information - Correction - Corzyme - (Abbott Laboratories) - 2/18/2005

Recall of Rapid HIV Test Kits - (Globus Media, Inc) - 2/4/2005

Recall of Amicus Apheresis Kits - (Baxter Healthcare Corporation) - 1/31/2005

Recall of Modified Alsever's Solution, Blood Cell Diluent - (Gamma Biologicals) - 1/25/2005

Recall of Blood Bank Devices - (Charter Medical, Ltd.) - 1/24/2005

Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - (Ortho-Clinical Diagnostics) - 1/19/2005

Market Withdrawal of HIV-1 / HCV Assay - Procleix - (Gen-Probe Inc) - 1/18/2005

Recall of Fetal Cell Screening Kit (FETALSCREEN) - (Ortho-Clinical Diagnostics) - 1/8/2005


2004

Recall of Leukocyte Reduction BPF4 High Efficiency Filter - (Pall Medical Corp) - 12/17/2004

Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection Systems - (Haemonetics Corp) - 10/18-26/2004 - Update

Notice of Field Correction: Automated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System - (Haemonetics Corp) - 10/18-26/2004

Recall of ORTHO Antibody to HBsAg ELISA Test System 3 - (Ortho Clinical Diagnostics, Inc) - 9/20/2004

Recall of Trima Accel LRS Tubing Sets - (Gambro BCT, Inc) - 8/16/2004

Recall of Amicus Separator Apheresis Device - (Baxter Healthcare Corp) - 7/21/2004

Recall of Limulus Amebocyte Lysate (LAL), Pyrotell - (Associates of Cape Cod, Inc) - 7/14/2004

Recall of Amplicor HIV-1 Monitor Test, v 1.5 - (Roche Molecular Systems, Inc) - 6/24/2004

Market Withdrawal of Immune Globulin Intravenous (Human), GAMMAGARD S/D, 10 gm - (Baxter SA) - 6/24/2004

Recall of NucliSens Automated Isolation Reagents for Use with NucliSens HIV-1 QT - (bioMerieux bv) - 5/17/2004

Medical Device Notification: HIV-1 / HIV-2 Plus O EIA Testing Software - (DiaSporin, Inc) - 5/13/2004

Recall of Ortho Assay Software (OAS)Version 2.0 (For Use with the Ortho Summit Sample Handling System) - (Ortho Clinical Diagnostics, Inc) - 5/13/2004

Recall of MTS Anti-IgG Card and MTS A/B/D Monoclonal and Reverse Grouping Card - (Micro Typing Systems, Inc) - 4/23/2004

Recall of Rabies Vaccine (Human Diploid Cell), Imovax Rabies - (Aventis Pasteur) - 4/2/2004

Recall of Immune Globulin Intravenous (Human), Gammar-P I.V., 10 gm - (Aventis Behring L.L.C.) - 4/1/2004

Recall of Allergenic Extracts - (Hollister-Stier Laboratories LLC) - 3/12/2004

Recall of Blood Bank Data Management System Software - (Information Data Management) - 1/9/2004


2003

Recall of Reagent Red Blood Cells, 0.8%, Selectogen - (Ortho Cinical Diagnostics Inc) - 12/23/2003

Recall of Immune Globulin Intravenous (Human) Gammar-P I.V., 10 gm - (Aventis Behring LLC) - 12/19/2003

Recall of Ortho Assay Protocol Diskette (OAPD) (For Use with the Ortho Summit Sample Handling System) - (Ortho Clinical Diagnostics, Inc) - 12/1/2003

Recall of Abbott PRISM System, Automated bloodborne pathogen test equipment - (Abbott Laboratories) - 11/21/2003

Recall of Sterile Water for Injection, USP, packed with Antihemophilic Factor/von Willebrand Factor Complex (Human), Humate-P - (Aventis Behring, LLC) - 11/3/2003

Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune-N - (Bayer Corp) - 10/3/2003 (Updated 10/16/2003)

Recall of Rabies Vaccine, IMOVAX Rabies - (Aventis Pasteur, Inc) - 9/9/2003

Recall of Capture Platelets, Capture-P Ready-Screen test kits - (Immucor, Inc) - 8/11/2003

Recall of Blood Bank Data Management System Software - (Soft Computer Consultants, Inc.) - 3/21/2003

Recall of Triple Blood-Pack Unit with PL 732 Transfer Pack - (Baxter Healthcare / Fenwal Division) - 3/17/2003

Recall of OPD Tablets Component of Ortho HCV Elisa, Ortho Antibody to HBsAg Elisa, and Ortho HBc Elisa Tests - (Ortho-Clinical Diagnostics) - 3/19/2003

Recall of Coagulation Factor IX (Human), AlphaNine SD - (Alpha Therapeutic Corp) - 2/19/2003

Recall of Antibody to Human Immunodeficiency Virus, HIVAG-1 Monoclonal EIA Test Kit - (Abbott Labs) - 2/17/2003

Recall of HCV EIA 2.0 Test Kit - (Abbott Labs) - 1/6/2003

 
Updated: September 12, 2008