Browse Device Recalls

75 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 75 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 75 FDA device recalls.

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DateProductReasonClassFirm
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 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 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.
Sep 16, 2013 Carestream Vue PACS; UNLIMITED READING LIC ADD 10K 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 PWR Reading Basic SW 8 Pack 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 Enterprise SW StandAlone 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 25K 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; MX WEB SVR W/3 MX-RAD 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.
Aug 29, 2013 DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. b... Carestream Health Inc. has conducted a voluntary field action which includes the installation of ... Class II Carestream Health Inc.
Aug 29, 2013 CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A.... Carestream Health Inc. has conducted a voluntary field action which includes the installation of ... Class II Carestream Health Inc.
Jul 26, 2013 DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY... During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an a... Class II Carestream Health, Inc.
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.
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.
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.

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.