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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

Infrastructure

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

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Jun 18, 2024 SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis.... Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... Class II Angiodynamics, Inc.
Jun 18, 2024 BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Co... BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February ... Class II Embecta Corp.
Jun 17, 2024 Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programm... A subset of the handsets within the kit may not be able to complete the pairing process with the ... Class II Medtronic Neuromodulation
Jun 17, 2024 Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powere... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distr... Class II Abbott Diagnostics Technologies AS
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electricall... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-po... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered in... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-power... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Regard Kit containing the Microtek decanter Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. Class II ROi CPS LLC
Jun 17, 2024 Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered ... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-po... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered in... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infus... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infu... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 14, 2024 SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR3... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 t... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discrete photometric chemistry analyzer for clinical use. Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoa... Class II Beckman Coulter, Inc.
Jun 14, 2024 Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Alinity hq Analyzer, REF: 09P68-01 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then ... Class II Abbott Laboratories
Jun 14, 2024 SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Reso... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catal... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1,... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magneti... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC

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.