Browse Device Recalls
1,398 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,398 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 1,398 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 25, 2013 | DRX-Evolution with FF WS These products are permanently installed diagnost... | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) an... | Class II | Carestream Health, Inc. |
| Nov 25, 2013 | DRX-Evolution with CSH WS These products are permanently installed diagnos... | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) an... | Class II | Carestream Health, Inc. |
| Nov 25, 2013 | DR 7500 with FF WS These products are permanently installed diagnostic x-r... | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) an... | Class II | Carestream Health, Inc. |
| Nov 20, 2013 | ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses ... | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac... | Class II | CooperVision Inc. |
| Nov 20, 2013 | Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses,... | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac... | Class II | CooperVision Inc. |
| Nov 18, 2013 | IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 ... | During the current inspection of CMP Industries, the FDA Investigator discovered that the firm ha... | Class II | CMP Industries, Llc |
| Nov 6, 2013 | IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 ... | potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000... | Class II | Siemens Healthcare Diagnostics |
| Oct 25, 2013 | VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic P... | Class II | Ortho-Clinical Diagnostics |
| Oct 23, 2013 | ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaf... | The affected lots were exposed to a higher than acceptable level of particulate matter during man... | Class II | ConMed Corporation |
| Oct 23, 2013 | ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaf... | The affected lots were exposed to a higher than acceptable level of particulate matter during man... | Class II | ConMed Corporation |
| Oct 17, 2013 | VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Di... | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator K... | Class II | Ortho-Clinical Diagnostics |
| Oct 17, 2013 | VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnost... | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator K... | Class II | Ortho-Clinical Diagnostics |
| Oct 10, 2013 | VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chem... | Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing C... | Class II | Ortho-Clinical Diagnostics |
| Oct 9, 2013 | VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/... | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic P... | Class II | Ortho-Clinical Diagnostics |
| Oct 8, 2013 | enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5... | Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen S... | Class II | Ortho-Clinical Diagnostics |
| Oct 8, 2013 | enGen Track System with enGen Select v5.0 with autoverification enabled Pr... | Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen S... | Class II | Ortho-Clinical Diagnostics |
| Oct 4, 2013 | VITROS Chemistry Products COCM Reagent | Inaccurate quality control results. | Class II | Ortho-Clinical Diagnostics |
| Sep 24, 2013 | Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilir... | Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator ... | Class II | Siemens Healthcare Diagnostics |
| Sep 23, 2013 | ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental a... | Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue... | Class II | Ivoclar Vivadent, Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PA... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM ... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS ... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS ... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PA... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS i... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM P... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS ... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PAC... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS ... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is a... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PAC... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health Inc. |
| Sep 16, 2013 | Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM ... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un... | Class II | Carestream Health 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.