Class II U.S. Food and Drug Administration

B Braun Medical Inc Brand Name: B. Braun Product Name: 21GA Winged Infusion 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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-1482-2026
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
21000 units
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
4046964338434, 4046964338410

Products covered by this recall

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

Check your product

The notice names 15 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.

  • 4046964338434
  • 4046964338410

Lot or batch code

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

  • 0062004706
  • Exp 31MAR2032
  • 0062005799
  • Exp 30JUN2032
  • 0062006415
  • 0062006416
  • 0062023397
  • 0062024887

Best-by / use-by date

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

  • 31MAR2032
  • 30JUN2032
  • 31JUL2032 — 21000 units

Model or item number

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

  • 7A3842 Software Version
  • 7A3842

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 4046964338434, 4046964338410; lot code 0062004706, Exp 31MAR2032, 0062005799; best-by date 31MAR2032 or 30JUN2032; model number 7A3842 Software Version, 7A3842. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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