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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

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

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DateProductReasonClassFirm
Nov 7, 2014 Ceramic Femoral Head. Intended for use in total hip arthroplasty applica... Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (... Class II DePuy Orthopaedics, Inc.
Nov 6, 2014 ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to gu... Potential failure of a force feedback sensor that may result in continued movement of an operatin... Class II Zimmer Biomet, Inc.
Oct 30, 2014 ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to ... Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management a... Class II Roche Diabetes Care, Inc.
Oct 15, 2014 ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in ... Issuing a device correction because if the pin bushing is over loaded or inverted, there is the p... Class II DePuy Orthopaedics, Inc.
Oct 14, 2014 Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads ... To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal T... Class II Zimmer, Inc.
Oct 14, 2014 Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibi... To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal T... Class II Zimmer, Inc.
Oct 9, 2014 Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is i... Cleaning process validation failure. Class II Zimmer, Inc.
Oct 7, 2014 The Persona Tibial Articular Surface Inserter is a sterilizable instrument in... Affected product did not undergo heat treatment hardening step leading to the potential for defor... Class II Zimmer, Inc.
Oct 2, 2014 Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in ... Failed to meet established requirements for sterile barrier integrity due to a breach of the inne... Class II Zimmer, Inc.
Oct 1, 2014 Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 6... The affected products are missing polar boss threads. Class II Zimmer, Inc.
Sep 26, 2014 Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set ... MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by ... Class II Cook Medical Incorporated
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.

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.