Browse Device Recalls
3,099 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,099 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 3,099 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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. |
| Sep 11, 2013 | The Artis zee / zeego Angiography System is designed as a set of components t... | There is a potential issue on running Artis systems running software VC1x software if a network p... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 6, 2013 | Selenia Full Field Digital Mammography System with software versions 5.0.x an... | Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the ... | Class II | Hologic, Inc. |
| Sep 4, 2013 | McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, ... | Software malfunction may occur resulting in a certain combination of server configurations which ... | Class II | Mckesson Information Solutions LLC |
| Sep 3, 2013 | Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software ve... | When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 3, 2013 | ADVIA 2400 System Software V4.01. Performs assays for general and specialt... | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... | Class II | Siemens Healthcare Diagnostics |
| Sep 3, 2013 | ADVIA 1800 System Software V2.01. Performs assays for general and specialt... | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... | Class II | Siemens Healthcare Diagnostics |
| Sep 3, 2013 | ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for genera... | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... | Class II | Siemens Healthcare Diagnostics |
| Sep 3, 2013 | (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Urosko... | A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 3, 2013 | ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for genera... | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... | Class II | Siemens Healthcare Diagnostics |
| 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. |
| Aug 28, 2013 | Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with sof... | When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 26, 2013 | Merge Mammo is a multi-modality, vendor-neutral digital mammography workstati... | There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo vie... | Class II | GE Healthcare It |
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.