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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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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DateProductReasonClassFirm
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 The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitr... The performance of the assay no longer conforms to this statement in the Analytical Specificity s... Class II Becton Dickinson & Co.
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 ICT Serum Calibrator REF 146-03. For use in the calibration of the serum ... ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient ... Class II Abbott Laboratories
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 BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL... BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306... Class II Becton Dickinson & Company
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.
Jul 22, 2014 Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FN... 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 4.5 mm Malleolar Screw 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 21, 2014 Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS98... The bed head deck may fail to elevate as expected during normal operation. When the non-operatio... Class II GF Health Products, Inc./d.b.a.Basic American M...
Jul 21, 2014 Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Us... Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue t... Class II Medtronic MiniMed Inc.
Jul 18, 2014 Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic ... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete ... The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be ... Class III BD Biosciences, Systems & Reagents
Jul 18, 2014 Prisma M100 set. Product number 104182. Each set is packaged in a plastic pou... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic ... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flu... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kit... Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (sub... Class III Diagnostica Stago, Inc.
Jul 18, 2014 Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stri... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prisma M100 PRE pump infusion set. Product number 107791. Each set is package... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a pl... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Prod... RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister... Class II Smith & Nephew, Inc.
Jul 18, 2014 Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 0... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Mac... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device a... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MAR... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated
Jul 18, 2014 Prismaflex M100. Product number 106697. Each set is packaged in a plastic pou... Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors ... Class II Gambro Renal Products, Incorporated

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.