Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,550 FDA device recalls in 2012.

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DateProductReasonClassFirm
Jul 2, 2012 Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30c... Imaging artifact can occur on mammogram result Class II Beekley Corporation
Jul 2, 2012 Merge HEMO software. The International Normalized Ratio (INR) value displayed in the study report does not match the v... Class II Merge Healthcare, Inc.
Jul 2, 2012 Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomog... Philips Healthcare was notified that several of the sixteen bolts securing the brackets which sup... Class II Philips Medical Systems (Cleveland) Inc
Jul 2, 2012 EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceu... Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in ass... Class II Ethicon, Inc.
Jul 2, 2012 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North... Part of the lot received a lower concentration of citrate solution which may cause falsely lower ... Class II Greiner Bio-One North America, Inc.
Jun 29, 2012 Alaris Pump Module model 8100. Subsequent product code: FPA The Pump mo... The recall was initiated because Carefusion identified a potential risk associated with the Alari... Class I CareFusion 303, Inc.
Jun 29, 2012 Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... Class II Arjo, Inc. dba ArjoHuntleigh
Jun 29, 2012 Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Prod... ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... Class II Arjo, Inc. dba ArjoHuntleigh
Jun 29, 2012 BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS... Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. Class II BD Biosciences, Systems & Reagents
Jun 29, 2012 Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... Class II Arjo, Inc. dba ArjoHuntleigh
Jun 29, 2012 Bard Foley procedural trays packaged in breather bags. The product is packag... Incomplete seal on sterile packages of product. Class II C.R. Bard, Inc., Urological Division
Jun 29, 2012 MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporat... The MXR-35 X-ray Generator's labeling did not include the certification statement as required by ... Class II Fujifilm Medical System USA, Inc.
Jun 28, 2012 STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, pac... Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biolo... Class II Advanced Sterilization Products
Jun 28, 2012 VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged... Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use... Class II Ortho-Clinical Diagnostics
Jun 28, 2012 GE Healthcare, AW Server. Product Usage: . AW Server is a medical softwar... GE Healthcare has recently become aware of a potential safety issue with respect to the Results V... Class II GE Healthcare, LLC
Jun 27, 2012 Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. There exists a potential situation with the crimp connection at the pump head assembly. The pote... Class II Mar Cor Purification
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and preventio... The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy Syste... Class II KCI USA, Inc.
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Pr... Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for... Class II Perkinelmer
Jun 27, 2012 Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 ... HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , t... Class II Smiths Medical ASD, Inc.
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 26, 2012 "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CON... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monito... GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom ... Class II GE Healthcare, LLC
Jun 26, 2012 "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CO... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal... Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak In... Class I GE Healthcare, LLC
Jun 26, 2012 Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quicki... Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual... Class II Sunrise Medical (US) LLC
Jun 26, 2012 "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CON... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 US... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethyle... BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440... Class II Bridgepoint Medical
Jun 26, 2012 "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***... Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items ... Class II Linvatec Corp. dba ConMed Linvatec
Jun 25, 2012 ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version ... Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interl... Class II Siemens Medical Solutions USA, Inc
Jun 25, 2012 System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion ... Class II Terumo Cardiovascular Systems Corporation
Jun 25, 2012 System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicate... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctio... Class II Terumo Cardiovascular Systems Corporation
Jun 25, 2012 System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctio... Class II Terumo Cardiovascular Systems Corporation
Jun 25, 2012 System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion ... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicate... Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of driv... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicat... Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicate... Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of driv... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated... Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 Central Control Module for System 1: System 1 Base, 100/120V The Terumo Ad... Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusio... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo... Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for ... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo ... Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for ... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 Central Control Module for System 1: System 1 Base, 220/240V The Terumo Ad... Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusio... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The el... Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for ... Class II Terumo Cardiovascular Systems Corporation
Jun 21, 2012 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicat... Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons ... Class II Terumo Cardiovascular Systems Corporation
Jun 21, 2012 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicat... Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons ... Class II Terumo Cardiovascular Systems Corporation
Jun 21, 2012 Monaco Product Usage: Planning of radiation therapy Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM ... Class II Elekta, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.