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Browse Device Recalls

50 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 50 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 50 FDA device recalls.

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DateProductReasonClassFirm
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
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
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Jun 24, 2014 Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits... Potential for inadvertent scalpel stick injury involving the safety scalpel. Class II Bard Access Systems
Apr 28, 2014 Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems O... Greatbatch identified that the documentation does not support the five-year shelf life of the Bar... Class II Greatbatch Medical
Feb 27, 2014 PowerPort Slim Implantable Port, indicated for patient therapies requiring re... Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, h... Class II Bard Access Systems
Dec 6, 2013 MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Pr... Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet... Class II Bard Access Systems
Dec 6, 2013 Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone... Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet... Class II Bard Access Systems
Jun 10, 2013 StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single U... BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices... Class II Bard Access Systems
Feb 21, 2013 Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff wit... Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 Frenc... Class II Bard Access Systems
Feb 21, 2013 Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff wi... Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 Frenc... Class II Bard Access Systems
Aug 7, 2012 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit con... Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters be... Class III 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.