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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

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Sep 26, 2014 Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments ar... An investigation identified that high level friction may exist between the needle and Mamba sutur... Class II Biomet, Inc.
Sep 26, 2014 Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instrume... An investigation identified that high level friction may exist between the needle and Mamba sutur... Class II Biomet, Inc.
Sep 26, 2014 Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments ar... An investigation identified that high level friction may exist between the needle and Mamba sutur... Class II Biomet, Inc.
Sep 25, 2014 ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo ... The insulin pump may lose time and date settings during a power interruption (such as a battery c... Class II Roche Diagnostics Operations, Inc.
Sep 24, 2014 Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a varie... An investigation identified that the product was incorrectly manufactured as a left humeral trial... Class II Biomet, Inc.
Sep 17, 2014 Compress Face Reamer Product Usage: Correction of revision of unsuccess... Investigation determined that units supplied were missing the 4x21 degree helix angle. Class II Biomet, Inc.
Sep 12, 2014 Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roch... The default references for normal values are inconsistent between cobas b 221 and other blood gas... Class III Roche Diagnostics Operations, Inc.
Sep 9, 2014 Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile... The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cort... Class II Zimmer, Inc.
Sep 5, 2014 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... The software issue described was corrected in the modification to the MXTTOUT controller paramete... Class II Zimmer Biomet, Inc.
Sep 3, 2014 RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as... Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in... Class II DePuy Orthopaedics, Inc.
Aug 27, 2014 Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International ... The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. Class II DePuy Orthopaedics, Inc.
Aug 14, 2014 Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ ... Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unope... Class II Biomedix, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Tibial Articular Surface Provisional Lef... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Constrained Tibial Articular Surface Pro... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Jul 31, 2014 Roche cobas IT 1000 Product Usage: Intended Use: An electronic device int... Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives ... Class II Roche Diagnostics Operations, Inc.
Jul 30, 2014 Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical... Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. Class II Zimmer, Inc.
Jul 30, 2014 Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Tro... Internal review found that five (5) PFJ implant forgings were identified as have forged laps duri... Class II Zimmer, Inc.
Jul 25, 2014 ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9... Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. Class II OrthoPediatrics Corp
Jul 23, 2014 VER2 D8L OFFSET RASP HANDLE, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left) The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 VER2 HANDLE, PIN REWORK, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 VER2 HANDLE, PIN REWORK, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 23.5 Deg Rasp Handle Assy- LEFT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right) The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Right Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 VER2 DBL OFFSET RASP HANDLE, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 VI DBL OFFST W/ LRG STPL, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 23.5 Deg Rasp Handle Assy- RIGHT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Right Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Vl DBL OFFST WI LRG STPL, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 22, 2014 4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zi... Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105L... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG ... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile... Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLA... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MI... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, 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.