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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

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
Nov 30, 2023 Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... Class I Busse Hospital Disposables, Inc.
Nov 30, 2023 Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... Class I Busse Hospital Disposables, Inc.
Nov 27, 2023 VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog ... Affected lots may experience increased calibration failures or an increase in falsely elevated re... Class II Ortho-Clinical Diagnostics, Inc.
Nov 21, 2023 QMS Tacrolimus Calibrators, Product code 10015573 Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry dat... Class II Ortho-Clinical Diagnostics, Inc.
Oct 25, 2023 VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITR... Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coa... Class II Ortho-Clinical Diagnostics, INc.
Oct 10, 2023 VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Prod... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Co... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 VITROS XT 7600 Integrated System Product Code 6844461 Running Software Versio... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Cod... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 2, 2023 The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system ut... There is a potential for unexpected failure of the electrical components within the Carestream He... Class II Carestream Health, Inc.
Oct 2, 2023 DRX Revolution Mobile X-Ray System Unexpected failure of electrical components within the CPI generator. Class II Carestream Health, Inc.
Sep 12, 2023 VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 S... Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cau... Class II Ortho-Clinical Diagnostics, INc.
Aug 9, 2023 Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry Sy... Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactur... Class II Ortho-Clinical Diagnostics, Inc.
Aug 8, 2023 ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 ... There is a potential for a positive bias on Quality Control (QC) and patient sample results when ... Class II Siemens Healthcare Diagnostics, Inc.
Aug 5, 2023 VITROS XT Chemistry Products TBIL-ALKP Slides Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... Class II Ortho-Clinical Diagnostics, INc.
Aug 5, 2023 VITROS XT Chemistry Products ALKP Slides Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... Class II Ortho-Clinical Diagnostics, INc.
Jul 25, 2023 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 1... There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 20, 2023 PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the su... Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthal... Class II Reichert, Inc.
Jul 10, 2023 Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative det... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative d... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative d... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quanti... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
May 19, 2023 Contour¿ next GEN Blood Glucose Monitoring System Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lo... Class II Ascensia Diabetes Care US, Inc.
May 18, 2023 VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro di... May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). Class III Ortho-Clinical Diagnostics, Inc.
May 10, 2023 Walnut Wearable Smart Thermometer, intended for continuous chest temperature ... There have been reports of skin burns to children wearing the device. Class I BearCare, Inc.
May 8, 2023 VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VI... Potential to cause biased results in the upper end of the reportable range for the quantitative m... Class II Ortho-Clinical Diagnostics
Apr 6, 2023 Fisher Wallace Stimulator Models FW-100 and FW-200 If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, d... Class II Fisher Wallace Laboratories Inc.
Apr 5, 2023 ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibra... Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... Class II Siemens Healthcare Diagnostics, Inc.
Apr 5, 2023 Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calib... Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... Class II Siemens Healthcare Diagnostics, Inc.
Mar 16, 2023 ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol... There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) resul... Class II Siemens Healthcare Diagnostics, Inc.
Mar 16, 2023 Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10... There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) resul... Class II Siemens Healthcare Diagnostics, Inc.
Mar 2, 2023 NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgic... Not programmed in accordance with specification. The programming affects the RFID function and do... Class II Angiodynamics, Inc.
Feb 14, 2023 Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses ... Class II CooperVision, Inc.
Jan 30, 2023 Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test fo... Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Contr... Class II Siemens Healthcare Diagnostics, Inc.
Jan 30, 2023 DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For ... After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead ... Class II Carestream Health, Inc.
Jan 27, 2023 Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative dete... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH Total Protein II- In vitro diagnostic use in the quantitative det... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative de... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 27, 2023 Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quant... Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... Class II Siemens Healthcare Diagnostics, Inc.
Jan 26, 2023 Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (e... Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... Class II CooperVision, Inc.
Jan 26, 2023 Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... Class II CooperVision, Inc.
Dec 27, 2022 MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Con... Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor vis... Class II CooperVision, Inc.
Dec 7, 2022 IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMUL... Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... Class II Siemens Healthcare Diagnostics, Inc.
Dec 7, 2022 IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMUL... Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... Class II Siemens Healthcare Diagnostics, Inc.
Dec 5, 2022 Turbett Surgical Container, TS1200: Indicated for enclosing other medical dev... Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr... Class II Turbett Surgical, Inc.
Dec 5, 2022 Turbett Surgical Container, TS1000: Indicated for enclosing other medical dev... Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr... Class II Turbett Surgical, Inc.
Nov 18, 2022 Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction C... Suction ports may potentially be occluded on the affected devices. If this occurs, the affected d... Class II ConMed Corporation
Nov 17, 2022 VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quanti... Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPT... Class II Ortho-Clinical Diagnostics, Inc.
Oct 21, 2022 Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... Class II Busse Hospital Disposables, 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.