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 |
|---|---|---|---|---|
| Mar 11, 2025 | BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK... | Catheters indicated for short-or-long term access to the central venous system have tubing that e... | Class I | Bard Access Systems, Inc. |
| Jun 20, 2022 | Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle ... | BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from in... | Class I | Bard Access Systems, Inc. |
| Nov 3, 2014 | GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer:... | Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they wer... | Class II | Bard Access Systems |
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.