Browse Device Recalls
5 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5 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 5 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 9, 2025 | Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K... | Cathode ray tube display system encoders and decoders have same MAC address; new system setup wit... | Class II | Barco N.V. |
| Apr 24, 2024 | MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display | We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050... | Class II | Barco N.V. |
| Dec 20, 2023 | Barco MDSC-8527 NXF, Part Number K9352421 | Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch o... | Class II | Barco N.V. |
| Jan 22, 2021 | Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY | A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will ... | Class II | Barco N.V. |
| Mar 30, 2017 | Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. ... | If metal strips are removed and re-applied to another display, there is potential for the metal s... | Class II | Barco N.V. |
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.