FDA recall, , Moderate risk
B. Braun 21G Winged Infusion Sets
B. Braun winged infusion sets may have a dull or blunt needle tip that can be difficult to advance or break.
Summary by Recall Canary from the FDA notice
What happened
B. Braun Medical Inc, of Bethlehem, Pennsylvania, recalled certain winged infusion sets because of the potential for the needle tip to be dull/blunt, difficult to advance, and/or break. The recalled products include the 21GA WINGED INF SET, the BBraun Medical 21G X4.4CM Winged INF, and the 21GA WINGED INFUSION, SINGLE PK, all intended for subcutaneous implantation to expand tissue expanders.
The recall began February 2, 2026, and was added to the FDA's Enforcement Report on March 2, 2026, with distribution in Texas and Costa Rica.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
3 products
Match the UDI-DI and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
B. Braun 21GA Winged Infusion, Single PK
- UDI-DI
- 4046964338434
- 4046964338410
- 0062004706
- 0062005799
- 0062006415
- 0062006416
- 0062023397
- 0062024887
- Model/Catalog number
- 7A3842
B. Braun 21GA Winged INF Set
- UDI-DI
- 4046964787102
- 4046964349904
- 0062003864
- 0062004133
- 0062006454
- 0062028929
- 0062037141
- 0062037691
- Model/Catalog number
- 7M2802
B. Braun BBraun Medical 21G X4.4CM Winged INF
- UDI-DI
- 4046964341298
- 4046964341274
- 0062006430
- 0062006470
- 0062006471
- 0062014964
- 0062014965
- 0062014966
- 0062027579
- Model/Catalog number
- 7B3050
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the state of Texas and the country of Costa Rica.
- Company
- B Braun Medical IncBethlehem, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98380
- Recall numbers
- Z-1481-2026 to Z-1483-2026
All recalls from B Braun Medical Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
