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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

1,398 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,398 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 1,398 FDA device recalls in NY.

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DateProductReasonClassFirm
Nov 12, 2020 Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic pr... Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which c... Class II ConMed Corporation
Nov 12, 2020 Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic pr... Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which c... Class II ConMed Corporation
Nov 11, 2020 Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001... The device was assembled with the incorrect exhalation port which can cause gas leakage. Class II Intersurgical Inc
Oct 26, 2020 Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers d... Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef b... Class II Siemens Healthcare Diagnostics, Inc.
Oct 26, 2020 Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers d... Test Definition scanning may reset custom settings to defaults causing falsely low or high result... Class II Siemens Healthcare Diagnostics, Inc.
Oct 14, 2020 Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous ... 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator co... Class II Angiodynamics, Inc.
Sep 29, 2020 v|tome|x L Series non-destructive testing cabinet x-ray systems It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning si... Class II Ge Inspection Technologies Llc
Sep 22, 2020 Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the qu... Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring ra... Class II Siemens Healthcare Diagnostics, Inc.
Sep 22, 2020 ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in th... Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring ra... Class II Siemens Healthcare Diagnostics, Inc.
Sep 17, 2020 LOM Disposable Surgical Gowns/Medical Gowns, Single-Use Medical gowns distributed to customers did not include appropriate labeling, and some gowns may n... Class II THREAD COUNSEL INC DBA LAWS OF MOTION
Jul 20, 2020 VITROS XT3400 Chemistry System, Product code 6844458 When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. A... Class II Ortho Clinical Diagnostics
Jul 20, 2020 VITROS XT7600 Integrated System, Product code 6844461 When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. A... Class II Ortho Clinical Diagnostics
Jul 17, 2020 VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6... The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu... Class II Ortho Clinical Diagnostics
Jul 17, 2020 VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog numbe... The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu... Class II Ortho Clinical Diagnostics
Jul 13, 2020 VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS ... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... Class II Ortho-Clinical Diagnostics
Jul 13, 2020 VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic q... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... Class II Ortho-Clinical Diagnostics
Jul 13, 2020 VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... Class II Ortho-Clinical Diagnostics
Jun 26, 2020 PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat pati... While operating the machine in "Run" mode an unexcepted event may occur during the error-checking... Class II Precision Valve & Automation,Inc
Jun 18, 2020 Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- R... FDA revocation of the Emergency Use Authorization due to performance issues Class II Chembio Diagnostics, Inc
Jun 18, 2020 Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for th... FDA revocation of the Emergency Use Authorization due to performance issues Class II Chembio Diagnostics, Inc
Jun 18, 2020 Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapi... FDA revocation of the Emergency Use Authorization due to performance issues Class II Chembio Diagnostics, Inc
Jun 5, 2020 Atellica CH Chemistry Calibrator Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... Class II Siemens Healthcare Diagnostics, Inc.
Jun 5, 2020 ADVIA Chemistry Calibrator Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... Class II Siemens Healthcare Diagnostics, Inc.
May 20, 2020 VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Un... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS 5600 Integrated System Software Versions 3.3.3 and below Product C... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Produ... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Produc... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 15, 2020 (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN)... Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... Class II Siemens Healthcare Diagnostics, Inc.
May 15, 2020 (1) CentraLink Data Management System software version 16.0.2 Siemens Materia... Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... Class II Siemens Healthcare Diagnostics, Inc.
May 11, 2020 VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 11, 2020 VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI #... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 11, 2020 VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Produc... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 11, 2020 VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # ... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 7, 2020 Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00... Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample ... Class II Siemens Healthcare Diagnostics, Inc.
May 7, 2020 Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00... Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample ... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: Thes... Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... Class II Angiodynamics, Inc.
May 4, 2020 BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated fo... Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... Class II Angiodynamics, Inc.
May 4, 2020 BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are ... Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... Class II Angiodynamics, Inc.
May 4, 2020 BioFlo Midline Convenience Kits - Product Usage: These introducers are used f... Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled... Class II Angiodynamics, Inc.
Apr 24, 2020 AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Ele... Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes t... Class II Angiodynamics, Inc.
Apr 1, 2020 VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8... The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plas... Class II Ortho-Clinical Diagnostics
Apr 1, 2020 VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 80011... The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plas... Class II Ortho-Clinical Diagnostics
Mar 10, 2020 VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. Class III Ortho Clinical Diagnostics
Feb 27, 2020 Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software vers... Editing an assay Test Definition and switching to another assay s Test Definition screen without ... Class II Siemens Healthcare Diagnostics, Inc.
Feb 14, 2020 Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 1109... The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibratio... Class II Siemens Healthcare Diagnostics, Inc.
Feb 5, 2020 IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - ... Due to high discordant Estradiol results which.potentially affects all patient populations, A fal... Class II Siemens Healthcare Diagnostics, Inc.
Feb 5, 2020 IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L... Due to high discordant Estradiol results which.potentially affects all patient populations, A fal... Class II Siemens Healthcare Diagnostics, Inc.
Jan 29, 2020 Class IV New Era medical laser device The firm failed to comply with the applicable standards regarding Electronic Product Radiation Co... Class II Inova Lasers LLC
Jan 13, 2020 Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydro... Incorrect power of lenses than the expected Class II CooperVision 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.