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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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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

1,382 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,382 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 1,382 FDA device recalls in NY.

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DateProductReasonClassFirm
May 10, 2018 RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M183481 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Nu... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL XPP KIT, Catalog Number 60M183104 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Numbe... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numb... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidew... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PICC, Catalog Number 60M071831 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M181578 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M150373 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 119... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 CAN 5F DUAL XCELA PICC, Catalog Number 60M701532 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and c... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire P... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 5F DL BIOFLO PICC, Catalog Number 60M180592 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS TANDEM 5F DL XPP, Catalog Number 60M019881 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Nu... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M132324 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 5F DL BIOFLO PASV, Catalog Number 60M141006 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 9, 2018 VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diag... There is a potential for imprecise results when using the slides. Increase in imprecision when u... Class II Ortho-Clinical Diagnostics
May 8, 2018 Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightS... In certain eyepiece configurations the laser shutter may not close completely, permitting reflect... Class II Zeiss, Carl Inc
May 8, 2018 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), inf... The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... Class II Baxter Healthcare Corporation
May 8, 2018 Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DI... The device is equipped with a dial that has an inaccurate flow rate indicator. Class II Dynarex Corporation
May 8, 2018 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), inf... The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... Class II Baxter Healthcare Corporation
May 5, 2018 VITROS Sodium Slides, Catalog # 837 9034 Potential for positively biased results Class II Ortho-Clinical Diagnostics
Apr 30, 2018 PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a pro... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Apr 30, 2018 PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Apr 25, 2018 Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. ... When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadv... Class II Intersurgical Inc
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Mar 27, 2018 ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on A... Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results ca... Class II Siemens Healthcare Diagnostics, Inc.
Mar 12, 2018 Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10... Incorrect calibrator level listed in qualitative calibration steps Class III Siemens Healthcare Diagnostics, Inc.
Mar 12, 2018 Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 104... Incorrect calibrator level listed in qualitative calibration steps Class III Siemens Healthcare Diagnostics, Inc.
Feb 26, 2018 Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic t... When more than one immunoassay analyzer is connected to a single solution system, reporting and c... Class II Siemens Healthcare Diagnostics, Inc.
Feb 26, 2018 Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. When more than one immunoassay analyzer is connected to a single solution system, reporting and c... Class II Siemens Healthcare Diagnostics, Inc.
Feb 26, 2018 Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing... When more than one immunoassay analyzer is connected to a single solution system, reporting and c... Class II Siemens Healthcare Diagnostics, 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.