Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N

FDA device recall Z-1481-2026 · posted 2026-03-02 · Open, Classified

Recall details

Recalling firm

B Braun Medical Inc

Reason for recall

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

Action taken

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

Status

Open, Classified

Product code

LCJ

Quantity affected

105550 units

Distribution

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

Date initiated

2026-02-02

Date posted

2026-03-02

Location

Bethlehem, PA