Browse Device Recalls

22 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 22 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 22 FDA device recalls.

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DateProductReasonClassFirm
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.
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.

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.