Class II U.S. Food and Drug Administration

B Braun Medical Inc Brand Name: B. Braun Product Name: 21GA Winged INF SET Model/ recall: The potential for the needle tip to be dull/blunt

Recall published 8 months ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1483-2026
Published
March 11, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
B Braun Medical Inc
Product type
Medical devices
Units affected
51300 units
Distribution
Nationwide
Made in
United States
Lot / code info
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.
UPC codes
4046964787102, 4046964349904

Products covered by this recall

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

Check your product

The notice names 22 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 4046964787102
  • 4046964349904

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0062003864
  • Exp 30APR2032
  • 0062004133
  • Exp 30JUN2032
  • 0062006454
  • Exp 31JUL2032
  • 0062028929
  • Exp 31AUG2032
  • 0062037141
  • Exp 30SEP2032
  • Lot 0062037691

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 30APR2032
  • 30JUN2032
  • 31JUL2032
  • 31AUG2032
  • 30SEP2032
  • Lot 0062037691
  • Exp 30SEP2032

Model or item number

On the rating label, the box or the instruction sheet.

  • 7M2802 Software Version
  • 7M2802

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

B Braun Medical Inc — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: B Braun Medical Inc — 824 12th Ave, Bethlehem, PA, 18018-3524

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was B Braun Medical Inc medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 4046964787102, 4046964349904; lot code 0062003864, Exp 30APR2032, 0062004133; best-by date 30APR2032 or 30JUN2032; model number 7M2802 Software Version, 7M2802. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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