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
Dec 27, 2012 Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalo... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 1391... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 13911... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulatio... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulati... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 13, 2012 SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patien... SR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts af... Class II Sr Instruments Inc
Dec 13, 2012 Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartri... Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly co... Class II Ortho-Clinical Diagnostics
Nov 28, 2012 Immunoradiometric assay. Device is an immunoradiometric assay designed for... The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... Class III Siemens Healthcare Diagnostics
Nov 28, 2012 Immunoradiometric assay. The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... Class III Siemens Healthcare Diagnostics
Nov 28, 2012 Immunoradiometric assay. Device is an immunoradiometric assay designed for... The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... Class III Siemens Healthcare Diagnostics
Nov 20, 2012 WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needle... ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... Class II ConMed Corporation
Nov 20, 2012 WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needle... ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... Class II ConMed Corporation
Nov 20, 2012 WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needle... ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... Class II ConMed Corporation
Nov 20, 2012 WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needle... ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... Class II ConMed Corporation
Nov 15, 2012 Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) an... Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (... Class II Viterion TeleHealthcare Llc
Nov 15, 2012 Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) an... Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (... Class II Viterion TeleHealthcare Llc
Nov 15, 2012 Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US... Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (... Class II Viterion TeleHealthcare Llc
Nov 1, 2012 VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B sur... Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an ina... Class III Ortho-Clinical Diagnostics
Oct 10, 2012 Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP C... Correlation slope bias and accuracy shift Class III Siemens Healthcare Diagnostics, Inc.
Aug 31, 2012 Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Modu... Posterior fluidics modules installed in the system may need to be recalibrated. Class II Bausch & Lomb Inc
Jul 19, 2012 Laserworld RGB & Piko Nano RGB Models All models are laser light show proj... A potential lack of certification, and/or missing laser certification, laser safety warning and a... Class II Laserworld Usa Inc
Jun 28, 2012 VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged... Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use... Class II Ortho-Clinical Diagnostics
Jun 15, 2012 AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size:... AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter ... Class II Angiodynamics Worldwide Headquarters
Jun 12, 2012 Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc... Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium... Class II Carestream Health, Inc.
May 29, 2012 Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code... The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as run... Class III Clark Laboratories, Inc. (dba,Trinity Biotech USA)
May 25, 2012 Getinge brand --- large capacity, floor loading jet spray, washers for mechan... Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heate... Class II Getinge USA Inc
May 21, 2012 VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi ... software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... Class II Ortho-Clinical Diagnostics
May 21, 2012 VITROS 4600 Chemistry System Software For use in the in-vitro quantitativ... software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... Class II Ortho-Clinical Diagnostics
May 21, 2012 VITROS 5600 Integrated System Software For use in the in-vitro quantitati... software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... Class II Ortho-Clinical Diagnostics
Apr 27, 2012 Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class ... Class II Motorola Inc
Apr 23, 2012 SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. P... Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIG... Class III Sigma
Jul 6, 2011 Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library,... Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow condition... Class I Baxter Healthcare Corporation

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.