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Brand Name: B. Braun recallZ-1481-2026 · B Braun Medical Inc · initiated Feb 2, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1481-2026
Status
Open, Classified
Initiated by the company
Feb 2, 2026
Posted by the FDA
Mar 2, 2026
Recalling firm
B Braun Medical Inc
Quantity
105550 units
Product code
LCJ
Distribution
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.

Product description

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

Code information (models, lots, serial numbers)

Model/Catalog Number: 7B3050; Primary-DI 4046964341298, Unit of Use- DI 4046964341274; Lot 0062006430, Exp 30APR2032; Lot 0062006470, Exp 30JUN2032; Lot 0062006471, Exp 31MAY2032; Lot 0062014964, Exp 31JUL2032; Lot 0062014965, Exp 31JUL2032; Lot 0062014966, Exp 30SEP2032; Lot 0062027579, Exp 31AUG2032.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 98380).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page