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Recalls older than 5 years have been archived and can be obtained by placing a Freedom of Information (FOI) Request.
Medical Device Recall (PR09-0082-0): Cerner PathNet Blood Bank Donor - Cerner Corporation - 3/11/2009
Urgent Instruction Correction: Biotest Tango Automated Blood Bank Analyzer - Biotest AG-Dreieich - 2/26/2009
Urgent Notification: Package Insert Update for MLB2 Modified LISS Solution - Biotest AG - 2/12/2009
Field Correction for Component Pack packaged with Mononine (Coagulation Factor IX, Human) - CSL Behring - 11/20/2008
Urgent Medical Device Removal – AXP Processing Bagset - ThermoGenesis - 10/24/2008
Important Notification: Red Cell Collection Kits - Haemonetics Corporation - 9/8/2008
Recall of m2000sp Instrument - Abbott Molecular, Inc. - 8/25/2008
Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] - Genzyme Corporation - 8/22/2008
Recall: Antihemophilic Factor, Human - CSL Behring L.L.C. - 8/18/2008
Recall of m2000sp Instrument - Abbott Molecular - 6/30/2008
Correction of AUSZYME Monoclonal Assay - Abbott Laboratories - 6/12/2008
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
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: 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
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 White-Faced Hornet Venom Protein - Hollister Stier Laboratories LLC - 1/7/2008
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
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
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
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
- FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - Talkpaper - 2/7/2005
- Unapproved Home-Use Diagnostic Kits Marketed by Globus Media - Medwatch - 2/7/2005
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
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
- Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine - MMWR - 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
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