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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

1,382 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
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.
Jan 13, 2020 Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydro... Incorrect power of lenses than the expected Class II CooperVision Inc.
Jan 12, 2020 Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the ... Class II Siemens Healthcare Diagnostics, Inc.
Jan 6, 2020 Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diag... Carestream Health has discovered a potential safety problem that can lead to unintended movement ... Class II Carestream Health, Inc.
Jan 6, 2020 Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software... A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. Class II Siemens Healthcare Diagnostics, Inc.
Jan 6, 2020 Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software... A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. Class II Siemens Healthcare Diagnostics, Inc.
Dec 31, 2019 Koios DS Breast <series 1.0>. The device is a software application which assi... Affected software product versions were found during internal audit to have been marketed for sal... Class II Koios Medical, Inc.
Dec 20, 2019 ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. ... Firm has received customer complaints regarding failed calibrations and increased imprecision of ... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019 ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 There is a potential for falsely depressed creatinine results for patients on phenindione therapy... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019 Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 There is a potential for falsely depressed creatinine results for patients on phenindione therapy... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019 Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 There is a potential for falsely depressed creatinine results for patients on phenindione therapy... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019 Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 There is a potential for falsely depressed creatinine results for patients on phenindione therapy... Class II Siemens Healthcare Diagnostics, Inc.
Nov 19, 2019 MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated ... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD s... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Us... May result in readings outside of the expected accuracy range. Class II Angiodynamics, Inc.
Nov 19, 2019 Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product ... Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in... 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.