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 |
|---|---|---|---|---|
| Oct 11, 2016 | NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers... | The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit d... | Class II | Baylis Medical Corp * |
| Oct 28, 2015 | ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Steril... | Microcatheter may have circumferential defects (cracks) along its shaft. | Class II | Baylis Medical Corp * |
| Mar 30, 2015 | ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a s... | Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility tha... | Class II | Baylis Medical Corp * |
| Sep 23, 2013 | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, st... | The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sh... | Class I | Baylis Medical Corp * |
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.