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Open, Classified

Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A

FDA Recall Z-1482-2026 · Posted 2026-03-02

Recalling FirmB Braun Medical Inc
Recall StatusOpen, Classified
Product CodeLCJ
Date Initiated2026-02-02
Product Quantity21000 units

Reason for Recall

The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

Firm Action

On February 2, 2026 URGENT MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. Actions to be taken: 1. Review the notice in its entirety and ensure that all users in your organization are aware and informed about this voluntary recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the hospital/healthcare facility level. 2. Examine inventory for affected product, cease use and quarantine product subject to recall. Do not destroy any affected product. 5. Once we receive your Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs.

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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