Recall Weekly
Moderate riskFDA DeviceClass II

B. Braun tissue expander injection needle recalled for dull or broken tip

B. Braun's 21G winged injection needles used for tissue expander procedures may have dull, blunt, or broken needle tips. This can make the needle difficult to advance during use. The issue affects specific lot numbers with expiration dates through September 2032.

From the FDA notice · Read the official notice ↗ · All B. Braun recalls

What to do

  1. Check your supply for affected lot numbers (0062006430, 0062006470, 0062006471, 0062014964, 0062014965, 0062014966, 0062027579)
  2. Do not use needles with dull or damaged tips
  3. Contact B. Braun Medical Inc or your supplier for replacement or instructions
  4. Report any needle breakage or difficulty during use to FDA MedWatch
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
105550 units
Illnesses reported
None reported
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Classification
Class II
Recall number
Z-1481-2026

In the FDA's words

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 The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. 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. Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica. Affected quantity: 105550 units
Hazard
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

3 products in this recall

B. Braun winged infusion sets recalled for needle tip defect

B. Braun is recalling three models of 21-gauge winged infusion sets because the needle tip may be dull or blunt, difficult to advance, or break. The recall covers about 177,850 units distributed nationwide in the United States and in Costa Rica. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from B. Braun

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device