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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.