Z-1481-2026Class II

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

Name: Z-1481-2026 Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software...
Creator: B Braun Medical Inc
Published: 2026-02-02
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2026-02-02 / Open, Classified / root cause: manufacturing process

FDA source

B Braun Medical Inc began a recall of 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... on 2026-02-02. FDA classified it as Class II and gives the reason as "The potential for the needle tip to be dull/blunt, difficult to advance, and/or break". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1481-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-02
Posted: 2026-03-02
Recalling firm: B Braun Medical Inc
Product: 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
Product code: LCJ Tissue Expander And Accessories
Reason for recall: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 105550 units
Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1481-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1481-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-02
Z-1482-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-02
Z-1483-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-02

Product code LCJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)