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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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
Feb 17, 2012 GE Healthcare Carescape Patient Data Module with v2.0 software used with Sola... GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software ... Class II GE Healthcare, LLC
Feb 15, 2012 Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic ... A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates li... Class III Medtest Holdings, Inc.
Feb 14, 2012 Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Versio... Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that... Class I Smiths Medical ASD, Inc.
Feb 12, 2012 The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee d... OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small... Class II Ossur Americas, Inc.
Feb 9, 2012 Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Ma... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive... Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during su... Class II Integra LifeSciences Corp.
Feb 9, 2012 Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO b... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 8, 2012 The finger cots are made out of natural rubber. They are disposable products... The firm is initiating a field correction because the product(s) were missing the Latex Warning L... Class II Afassco Inc
Feb 6, 2012 VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay... The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; sp... Class II Accumetrics Inc
Feb 6, 2012 CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate bra... Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected ... Class II Metrex Research, LLC.
Feb 6, 2012 VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage... The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; sp... Class II Accumetrics Inc
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part:... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: Th... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PL... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 4, 2012 "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corpora... Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was upda... Class II Orthosensor
Feb 1, 2012 i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test i... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care Inc.
Feb 1, 2012 COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. ... Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip)... Class II Roche Molecular Systems, Inc.
Feb 1, 2012 i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care Inc.
Feb 1, 2012 i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is a... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care Inc.
Jan 31, 2012 Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up t... In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modify... Class II Abbott Molecular
Jan 27, 2012 IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 T... The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot... Class II Beckman Coulter Inc.
Jan 26, 2012 Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Pr... Stryker has become aware that there exists a potential for breach of the sterile barrier of packa... Class II Stryker Howmedica Osteonics Corp.
Jan 24, 2012 REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 23, 2012 VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139;... GE Healthcare has become aware of an issue associated with the base casting for the articulated a... Class II GE Healthcare, LLC
Jan 20, 2012 Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA... The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Ki... Class II Beckman Coulter Inc.
Jan 20, 2012 COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus... The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may expe... Class II Beckman Coulter Inc.
Jan 19, 2012 MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation),... The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boa... Class II Nihon Kohden America Inc
Jan 13, 2012 Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z... Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS... Class II Stryker Spine
Jan 10, 2012 Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automate... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog #... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automate... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Us... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: aut... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 9, 2012 "***Electric Systems Foot Control with Direction Only***Rx Only***" Produc... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due t... Class II The Anspach Effort, Inc.
Jan 9, 2012 "***Electric Systems Foot Control with Direction and Irrigation***Rx Only***"... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due t... Class II The Anspach Effort, Inc.
Jan 9, 2012 "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting a... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due t... Class II The Anspach Effort, Inc.
Jan 6, 2012 Hemostatic Bone Putty, for use as a water-soluble implant material and for u... Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead ... Class II Synthes, Inc.
Jan 5, 2012 Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is inte... Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant rep... Class II Cook Ireland Ltd.
Jan 4, 2012 GE Healthcare Muse v7 cardiology information system. Model number 2026443-00... GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on ... Class II GE Healthcare, LLC

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.