Browse Device Recalls
65 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 65 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 65 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. |
| May 19, 2021 | 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For U... | Catheter kits contained the incorrect micro-introducers. | Class II | Bard Access Systems Inc. |
| May 19, 2021 | 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire ... | Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 c... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Ext... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positionin... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 c... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positionin... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 c... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location Syste... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location Syste... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 ... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location Syste... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lum... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Jan 15, 2020 | BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Sept... | The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock pe... | Class II | Bard Peripheral Vascular Inc |
| Dec 28, 2017 | PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Pac... | Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub... | Class II | Bard Access Systems Inc. |
| Apr 25, 2017 | StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. ste... | StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. | Class II | Bard Access Systems Inc. |
| Dec 19, 2016 | MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S... | Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-... | Class II | Bard Access Systems |
| Dec 19, 2016 | SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Pa... | Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-... | Class II | Bard Access Systems |
| Dec 9, 2016 | StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a s... | Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization D... | Class II | Bard Access Systems |
| Dec 9, 2016 | StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged ... | Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization D... | Class II | Bard Access Systems |
| Jul 20, 2015 | Marketing brochures for the PowerPICC and PowerPICC SOLO catheters | Bard Access Systems is recalling marketing brochures for the PowerPICC¿ and PowerPICC¿ SOLO¿ cath... | Class II | Bard Access Systems |
| May 27, 2015 | PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray ... | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... | Class III | Bard Access Systems |
| May 27, 2015 | PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single... | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... | Class III | Bard Access Systems |
| May 27, 2015 | PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tra... | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... | Class III | Bard Access Systems |
| May 27, 2015 | PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full T... | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... | Class III | Bard Access Systems |
| Mar 13, 2015 | PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc... | Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum F... | 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.