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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Oct 4, 2023 BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20G... Over-the-needle, intravascular catheters may have needles that do not retract properly into the b... Class II Becton Dickinson Infusion Therapy Systems Inc.
Aug 29, 2023 REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 ... There is the potential that the safety shield may not properly engage on IV catheters. The needle... Class II Becton Dickinson Infusion Therapy Systems Inc.
Oct 12, 2022 BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (... During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and p... Class II Becton Dickinson Infusion Therapy Systems Inc.
Sep 8, 2021 BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Cathe... There is a breach in the product packaging that renders the product non-sterile. Class II Becton Dickinson Infusion Therapy Systems Inc.
Feb 19, 2015 BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #3... Becton Dickinson received an elevated number of complaints for blood or infusate/medication leaka... Class II Becton Dickinson & Company

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.