—#218532

Product

Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 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 product code: LCJ — Tissue Expander And Accessories
Device class: Class U
Medical specialty: Unknown
Affected lot / code info: Model/Catalog Number: 7M2802; Primary-DI 4046964787102, Unit of Use- DI 4046964349904; Lot 0062003864, Exp 30APR2032; Lot 0062004133, Exp 30JUN2032; Lot 0062006454, Exp 31JUL2032; Lot 0062028929, Exp 31AUG2032; Lot 0062037141, Exp 30SEP2032, Lot 0062037691, Exp 30SEP2032.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: B Braun Medical Inc
Address: 824 12th Ave, Bethlehem, Pennsylvania 18018-3524

Distribution

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

Timeline

Recall initiated: 2026-02-02
Posted by FDA: 2026-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218532. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.