Reported Mar 11, 2026 · Ongoing
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version:…
B Braun Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B Braun Medical Inc · 824 12th Ave · Bethlehem, PA · 18018-3524
Is this the product you have?
- Brand NameB
- Braun Product NameBBraun Medical 21G X4.4CM
- Winged INF Model/Catalog Number7B3050
- Software VersionN/A
- Product DescriptionA device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids
- ComponentN/A
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Barcodes Product as published 7B3050Model/ — 40469643412984046964341274Primary-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. - Amount recalled
- 105550 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- TX
Why it was recalled
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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