Browse Device Recalls
3 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3 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 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 16, 2025 | Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeut... | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch... | Class II | Scientia Vascular, Inc. |
| Jan 2, 2025 | Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socra... | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch... | Class II | Scientia Vascular, Inc. |
| Feb 1, 2023 | Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-... | Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature... | Class II | Scientia Vascular, Inc. |
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.