Browse Device Recalls
18 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 18 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 18 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 30, 2026 | BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit ... | After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or im... | Class I | Bard Access Systems, Inc. |
| May 21, 2026 | 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lu... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 ... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A ... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 ... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 008017... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PI... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 31731... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 0080174118877... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 0080174112160... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| 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.