Browse Device Recalls
4 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4 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 4 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 18, 2016 | McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 1... | McKesson has identified a design deficiency where under rare circumstances, imported images/studi... | Class II | Mckesson Medical Immaging |
| May 29, 2014 | Horizon Medical Imaging Horizon Medical Imaging is a medical image and inf... | Firm received a complaint that an unreported study performed that day could not be opened from th... | Class II | Mckesson Medical Immaging |
| May 5, 2014 | Horizon Medical Imaging It is a medical image and information management a... | The firm has identified a software issue which may cause a discrepancy between the index of image... | Class II | Mckesson Medical Immaging |
| Apr 17, 2014 | McKesson Radiology-PACS. McKesson Radiology is a medical image and informa... | High priority alert icon was not displayed in the Study List when there are no Stat studies prese... | Class II | Mckesson Medical Immaging |
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.