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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

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Mar 16, 2017 Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, a... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
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 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 7220404... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 722040... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Mo... The issue was identified as a firmware problem with the generator. Class II Toshiba American Medical Systems Inc
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hemat... Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer... Class II Avid Medical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 7220404... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome... Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead. Class II Richard-Allan Scientific Company
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, 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 14, 2017 NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS Sys... Software defect: the NBS software may accidentally generate duplicate copies of one or several fi... Class II Nexstim PLC
Mar 14, 2017 Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 P... During patient interventions with the urology table the radiation is activated with a footswitch ... Class II Hans Pausch Rontgengeratebau Gmbh
Mar 14, 2017 Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigat... Software defect: the NBS software may accidentally generate duplicate copies of one or several fi... Class II Nexstim PLC
Mar 13, 2017 Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1,... Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Conce... Class II Accelerate Diagnostics Inc
Mar 13, 2017 Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-... SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under t... Class II Valeant Pharmacueticals International
Mar 13, 2017 Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Proble... The Pause function on central monitors will not automatically resume when connected to a Life Sco... Class II Nihon Kohden America Inc
Mar 13, 2017 NEODENT CM Intraoral Scanbody, Article Number: 108.139 During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139... Class II Instradent USA, Inc.
Mar 13, 2017 Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Eso... The reusable temperature probes are provided with instructions for sterilization that have not be... Class II Measurement Specialties Inc
Mar 10, 2017 Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly... Class II GE Healthcare, LLC
Mar 10, 2017 Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD. GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly... Class II GE Healthcare, LLC
Mar 10, 2017 Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a ... Product shipped proximate to or past the expiration date listed on the product label. Class II Stryker Instruments Div. of Stryker Corporation
Mar 10, 2017 HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Prod... In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to th... Class I Heartware
Mar 10, 2017 Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibratio... Class II Beckman Coulter Inc.
Mar 9, 2017 Proteus 235 The Proton Therapy System can allow gantry rotation even if the snout is not properly locked. Class II Ion Beam Applications S.A.

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.