Class II U.S. Food and Drug Administration

B Braun Medical Inc Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM 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

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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-1481-2026
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
105550 units
Distribution
Nationwide
Made in
United States
Lot / code info
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.
UPC codes
4046964341298, 4046964341274

Products covered by this recall

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

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.

  • 4046964341298
  • 4046964341274

Lot or batch code

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

  • 0062006430
  • Exp 30APR2032
  • 0062006470
  • Exp 30JUN2032
  • 0062006471
  • Exp 31MAY2032
  • 0062014964
  • Exp 31JUL2032
  • 0062014965
  • 0062014966
  • Exp 30SEP2032
  • 0062027579

Best-by / use-by date

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

  • 30APR2032
  • 30JUN2032
  • 31MAY2032
  • 31JUL2032
  • 30SEP2032
  • 31AUG2032. — 105550 units

Model or item number

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

  • 7B3050 Software Version
  • 7B3050

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 — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  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.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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 4046964341298, 4046964341274; lot code 0062006430, Exp 30APR2032, 0062006470; best-by date 30APR2032 or 30JUN2032; model number 7B3050 Software Version, 7B3050. 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?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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