The Recall Desk
HighFDA (Devices)·Z-1481-2026·Announced 2026-03-11

B. Braun 21G 4.4 cm winged infusion needles may break

B. Braun Medical is recalling 21G x 4.4 cm Winged Infusion devices, model 7B3050, because the needle tip may be dull or blunt, difficult to advance, or may break.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a needle that may break or fail to advance during a procedure is a hazard, and no injuries are stated in the source.

Plain-English summary

B Braun Medical Inc is recalling the BBraun Medical 21G x 4.4CM Winged INF, model 7B3050. The device is designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. About 105,550 units were distributed in Texas and Costa Rica. The FDA has classified this recall as Class II.

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

Affected product carries Primary-DI 4046964341298 and Unit of Use DI 4046964341274, across lots 0062006430, 0062006470, 0062006471, 0062014964, 0062014965, 0062014966 and 0062027579, with expiry dates from April 2032 to September 2032.

Facilities can identify affected devices by the model number, DIs and lot numbers above, and may contact B Braun Medical Inc for further information.

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 percut
Manufacturer
B Braun Medical Inc
Category
Medical Device — Infusion
Hazard
Affected units
105,550

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 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
  • Lot 0062014966
  • Exp 30SEP2032
  • Lot 0062027579
  • Exp 31AUG2032.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · B Braun Medical Inc

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Same hazard · needle defect

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