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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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
Apr 28, 2017 VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 26, 2017 Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The ... Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Bas... Class II Zimmer Biomet, Inc.
Apr 25, 2017 Pereyra Ligature Carrier 75 reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotatin... A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requ... Class II Zimmer Biomet, Inc.
Apr 25, 2017 Pereyra-Raz Ligature Carrier reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Endoscopic Introducer/Extractor reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Stamey Needle reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Clarke-Reich Laparoscopic Knot Pusher reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 24, 2017 Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01... Over-tensioning of the band resulting in damage to the band causing it to rupture Class II OrthoPediatrics Corp
Apr 17, 2017 AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is ... nail not properly engaging with the targeting jig due to certain undersized specification Class II Zimmer Biomet, Inc.
Apr 17, 2017 SonarMed AirWave Monitor, Model Number M0001 Potential for the presence of two error codes which would make the monitor inoperable. Class II SonarMed Inc
Apr 13, 2017 Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gent... Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek pac... Class II Zimmer Biomet, Inc.
Apr 12, 2017 Bone Dowell Harvest Tubes mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously subst... Class II Zimmer Biomet, Inc.
Apr 10, 2017 Elecsys PreciControl Varia 3 e-barcode and value sheet for PreciControl Varia contains a typographical error for the target va... Class II Roche Diagnostics Corporation
Mar 22, 2017 Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endova... There have been five reports of graft thrombosis/occlusion during global commercial use, each fo... Class I Cook Medical Incorporated
Mar 22, 2017 Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM... pegs shearing post-operatively Class II Zimmer Biomet, Inc.
Mar 21, 2017 Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular ... Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and l... Class II Roche Diagnostics Corporation
Mar 15, 2017 UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390... Potential for leak test failures. Class II King Systems Corp. dba Ambu, Inc.
Mar 14, 2017 Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for... A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice ... Class II Roche Diabetes Care, Inc.
Mar 7, 2017 Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Cat... Product may overheat, melt, and burn patient. Class II Cook Inc.
Mar 1, 2017 Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Co... Class II Roche Diagnostics Corporation
Mar 1, 2017 Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the C... Class II Roche Diagnostics Corporation
Feb 28, 2017 Segmental fluted stem, 18x250mm bwd, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and acces... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and ac... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 16x200mm, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, se... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and acce... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary a... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and acce... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and ac... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, met... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 18x200mm, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, 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.