Browse Device Recalls

74 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 74 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 74 FDA device recalls.

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DateProductReasonClassFirm
Oct 2, 2023 The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system ut... There is a potential for unexpected failure of the electrical components within the Carestream He... Class II Carestream Health, Inc.
May 25, 2017 DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all othe... Carestream found a single unit where four screws in the assembly were not applied in the manufact... Class II Carestream Health Inc
Jan 12, 2017 Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019... The firm received a complaint alleging that a DRX Revolution System could not be stopped when app... Class II Carestream Health Inc
Nov 21, 2016 Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738... Software error; Carestream Health Inc, received a complaint stating that when a user accidentally... Class II Carestream Health Inc
Jul 8, 2016 Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE... A software issue related to the generic volume measurement functionality could result in the volu... Class II Carestream Health Inc
Apr 15, 2016 CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490... Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita... Class II Carestream Health Inc
Apr 15, 2016 CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1... Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospita... Class II Carestream Health Inc
Aug 7, 2015 CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a per... Software defect that impacts image alignment when using the automatic stitching option for long l... Class II Carestream Health Inc
Nov 25, 2014 DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog ... While servicing a unit at a customer site, a field engineer discovered a broken bolt from the car... Class II Carestream Health Inc
Jul 2, 2014 Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DE... The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... Class III Carestream Health Inc.
Jul 2, 2014 INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL... The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... Class III Carestream Health Inc.
May 30, 2014 KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and... A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Tec... Class II Carestream Health Inc.
Jan 24, 2014 Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 53... Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-... Class II Carestream Health Inc.
Jan 24, 2014 Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- ... Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-... Class II Carestream Health Inc.
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.
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.
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.

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.