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 |
|---|---|---|---|---|
| Jun 12, 2013 | VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog numbe... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog numbe... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 ... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog num... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog num... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 105318... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog numb... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog numb... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 6, 2013 | Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375,... | Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incuba... | Class II | Ortho-Clinical Diagnostics |
| Jun 6, 2013 | Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images. | Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System du... | Class II | Carestream Health, Inc. |
| Jun 3, 2013 | Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system i... | Due to potential for an x-ray exposure technique change. | Class II | Carestream Health Inc. |
| May 28, 2013 | Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss... | Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS micro... | Class II | Zeiss, Carl Inc |
| May 9, 2013 | VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number... | While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant ... | Class III | Ortho-Clinical Diagnostics |
| May 9, 2013 | VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 a... | While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amou... | Class III | Ortho-Clinical Diagnostics |
| May 6, 2013 | VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage:... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product cod... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | VITROS 5600 Integrated System (product code 6802413) Product Usage: For ... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 F... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ S... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 3, 2013 | PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 20... | ConMed was notified by the contract manufacturer that their wire/connector supplier reported dama... | Class II | ConMed Corporation |
| Apr 30, 2013 | AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following ... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Apr 30, 2013 | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioD... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Apr 24, 2013 | embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilato... | Calibration error for Embla Embletta Gold units calibrated through service center between June 15... | Class II | Embla System Llc |
| Apr 3, 2013 | VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho... | Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 de... | Class III | Ortho-Clinical Diagnostics |
| Apr 1, 2013 | VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 680... | The firm is recalling the specific lot due to lower than expected results. | Class II | Ortho-Clinical Diagnostics |
| Mar 28, 2013 | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV... | Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. | Class II | Transonic Systems Inc |
| Mar 14, 2013 | VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For t... | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outlie... | Class II | Ortho-Clinical Diagnostics |
| Feb 12, 2013 | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. ... | The test strips in the affected product lots of the OC Light immunological fecal occult blood tes... | Class II | Polymedco, Inc |
| Feb 12, 2013 | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. ... | The test strips in the affected product lots of the OC Light immunological fecal occult blood tes... | Class II | Polymedco, Inc |
| Feb 7, 2013 | VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemis... | Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems ... | Class II | Ortho-Clinical Diagnostics |
| Feb 7, 2013 | VITROS 5600 Integrated System, Product Code 6802413. Intended for use in t... | Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems ... | Class II | Ortho-Clinical Diagnostics |
| Feb 7, 2013 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Co... | Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems ... | Class II | Ortho-Clinical Diagnostics |
| Jan 28, 2013 | ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, D... | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where ... | Class II | ConMed Corporation |
| Jan 28, 2013 | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX... | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where ... | Class II | ConMed Corporation |
| Jan 17, 2013 | KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Mod... | Missing symbols and manufacturing information on the clear carton label. The expiration dating s... | Class III | Carestream Health, Inc. |
| Dec 27, 2012 | UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 13910... | ConMed received complaints of some devices which had broken through the seal of the sterile pouch... | Class II | ConMed Corporation |
| Dec 27, 2012 | CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Cata... | ConMed received complaints of some devices which had broken through the seal of the sterile pouch... | Class II | ConMed Corporation |
| Dec 27, 2012 | TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, ... | ConMed received complaints of some devices which had broken through the seal of the sterile pouch... | Class II | ConMed Corporation |
| Dec 27, 2012 | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tip... | ConMed received complaints of some devices which had broken through the seal of the sterile pouch... | Class II | ConMed Corporation |
| Dec 27, 2012 | Goldvac(TM) UltraClean(R) Accessory Electrode 6 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 | Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ... | 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 with Extended Insulati... | 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 Blade, REF/Catalog No. 13910... | ConMed received complaints of some devices which had broken through the seal of the sterile pouch... | Class II | ConMed Corporation |
| Dec 27, 2012 | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tip... | ConMed received complaints of some devices which had broken through the seal of the sterile pouch... | Class II | ConMed Corporation |
| Dec 27, 2012 | ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R... | ConMed received complaints of some devices which had broken through the seal of the sterile pouch... | Class II | ConMed Corporation |
| Dec 27, 2012 | ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Ca... | 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 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 | Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extend... | ConMed received complaints of some devices which had broken through the seal of the sterile pouch... | Class II | ConMed Corporation |
| Dec 27, 2012 | Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extend... | 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 Blade with Extended Insulatio... | ConMed received complaints of some devices which had broken through the seal of the sterile pouch... | Class II | ConMed 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.