Browse Device Recalls
10 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 10 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 10 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 8, 2025 | Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1... | Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lo... | Class II | Securitas Healthcare LLC |
| Dec 8, 2025 | Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version:... | Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lo... | Class II | Securitas Healthcare LLC |
| Nov 1, 2024 | Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjuncti... | Certain software versions will not notify end users of calls initiated by call points with the Ar... | Class II | Securitas Healthcare LLC |
| Jun 20, 2024 | Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireles... | This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and prema... | Class II | Securitas Healthcare LLC |
| Jun 20, 2024 | Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery... | There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and ... | Class II | Securitas Healthcare LLC |
| Apr 11, 2024 | Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that ut... | The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting caus... | Class II | Securitas Healthcare LLC |
| Sep 25, 2023 | Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-5936... | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles... | Class II | Securitas Healthcare LLC |
| Sep 25, 2023 | Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; ... | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles... | Class II | Securitas Healthcare LLC |
| Sep 25, 2023 | Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59... | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles... | Class II | Securitas Healthcare LLC |
| Feb 6, 2023 | Arial mobile application, model #54630 and #54640 for Android devices downloa... | The mobile application for Android devices downloaded from the Google Play Store do not load per ... | Class II | Securitas Healthcare LLC |
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.