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Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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DateProductReasonClassFirm
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 SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiot... The SmartSet¿ GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for ... Class II DePuy Orthopaedics, 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 COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers ... Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service A... Class II Roche Diagnostics Operations, 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 GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume ... GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance ... Class I GE Healthcare, LLC
Sep 16, 2013 STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Produ... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, 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 STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, 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 Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for Uni... Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. diffi... Class II Sekisui Diagnostics LLC
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 Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D,... Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformat... Class I Edwards Lifesciences, LLC
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 STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-24... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, 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.
Sep 16, 2013 NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; M... Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the ... Class II Medtronic Vascular, Inc.
Sep 16, 2013 Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR 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; MX WEB SW/1 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 SW/25 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-RAD SVR 15K 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 STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalo... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, Inc.
Sep 16, 2013 Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED 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; Virtual Access Pluse 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; UNLIMITED READING LIC < 25K 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 CLINIC SOFTWARE DICOM VIEWING 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 PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lowe... PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding ... Class I Pentax Medical Company
Sep 16, 2013 Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS 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 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; MX WEB SVR W/3 MX-O LIC < 15K 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 RAD SW ADV CR/DR LAYOUT & VIEW 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-RAD LIC<50K 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; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is ... 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.