The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1482-2026·Announced 2026-03-11

B. Braun 21GA winged infusion single packs may have blunt needles

B. Braun Medical is recalling 21GA Winged Infusion single packs, model 7A3842, because the needle tip may be dull or blunt, difficult to advance, or may break.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 21GA Winged Infusion, Single Pk, model 7A3842. 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 21,000 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 4046964338434 and Unit of Use DI 4046964338410, across lots 0062004706, 0062005799, 0062006415, 0062006416, 0062023397 and 0062024887, with expiry dates from March 2032 to July 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: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 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…
Manufacturer
B Braun Medical Inc
Category
Medical Device — Infusion
Hazard
Affected units
21,000

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 (12)

  • Model/Catalog Number: 7A3842
  • Primary-DI 4046964338434
  • Unit of Use- DI 4046964338410
  • Lot 0062004706
  • Exp 31MAR2032
  • Lot 0062005799
  • Exp 30JUN2032
  • Lot 0062006415
  • Lot 0062006416
  • Lot 0062023397
  • Lot 0062024887
  • Exp 31JUL2032

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 →

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