B. Braun 21GA Winged Inf Set Recall: Needle Tip May Be Dull or Break
B. Braun recalls 21GA Winged Inf Set model 7M2802 due to potential needle tip dullness or breakage during use. Affected units sold from 2020 to 2023 with specific lot numbers.
Lower-risk recall
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Contact the company
What happened, in plain English
B. Braun is recalling 21GA Winged Inf Sets with model number 7M2802 because the needle tip might become dull, difficult to advance, or break. This could cause problems during medical procedures if the needle doesn't function properly. Read more at govinfonow.com/recall/50057-b-braun-21ga-winged-inf-set-recall-needle-tip-may.
Source Summary by GovInfoNow · govinfonow.com/recall/50057-b-braun-21ga-winged-inf-set-recall-needle-tip-may · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1483-2026
Cite this page
“B. Braun 21GA Winged Inf Set Recall: Needle Tip May Be Dull or Break.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50057-b-braun-21ga-winged-inf-set-recall-needle-tip-may. Based on FDA recall #Z-1483-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1483-2026%22&limit=1).
Why it’s dangerous
The needle tip in these sets may become dull or blunt, making it harder to advance through tissue. If the needle breaks during use, it could cause complications like tissue damage or require additional medical intervention.
Who’s affected
Healthcare professionals and patients using the 21GA Winged Inf Set for temporary tissue expansion procedures are affected. Those with the specific model number 7M2802 and listed lot numbers are most at risk.
How to tell if you have this one
Check the model number on the product, which is 7M2802. The affected units were sold between 2020 and 2023 with specific lot numbers listed in the recall notice.
- Brand
B. Braun- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1481-2026 | 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; 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. | 105550 units |
| Z-1482-2026 | 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 percutaneous injection of air or fluids. Component: N/A; Model/Catalog Number: 7A3842; Primary-DI 4046964338434; Unit of Use- DI 4046964338410; Lot 0062004706, Exp 31MAR2032; Lot 0062005799, Exp 30JUN2032; Lot 0062006415, Exp 31MAR2032; Lot 0062006416, Exp 31MAR2032; Lot 0062023397, Exp 30JUN2032; Lot 0062024887, Exp 31JUL2032 | 21000 units |
| Z-1483-2026 | Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 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; Model/Catalog Number: 7M2802; Primary-DI 4046964787102, Unit of Use- DI 4046964349904; Lot 0062003864, Exp 30APR2032; Lot 0062004133, Exp 30JUN2032; Lot 0062006454, Exp 31JUL2032; Lot 0062028929, Exp 31AUG2032; Lot 0062037141, Exp 30SEP2032, Lot 0062037691, Exp 30SEP2032. | 51300 units |
What to do — step by step
Check Product Model
Look for the model number 7M2802 on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Which lot numbers are affected?
Affected lot numbers include 0062003864 (expiring April 30, 2032), 0062004133 (expiring June 30, 2032), 0062006454 (expiring July 31, 2032), 0062028929 (expiring August 31, 2032), and 0062037141 (expiring September 30, 2032).
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1483-2026 (February 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1483-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.