HIGHFDA DEVICE

B. Braun Medical Recalls BBraun Medical 21G Winged INF 7B3050 for 105,550 Units (2026)

B. Braun Medical recalled 105,550 BBraun Medical 21G X4.4CM Winged INF devices worldwide, including Texas and Costa Rica. A dull or blunt needle tip may be difficult to advance or break. Healthcare providers and patients should stop using the device and follow the manufacturer's recall instructions.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
February 2, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
February 2, 2026
Hazard Level
HIGH
Brand
B. Braun Medical
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
B. Braun Medical
Product type
Winged infusion needle
Model numbers
7B3050
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 2, 2026

  2. Reported by FDA DEVICE

    March 11, 2026

  3. RecallRadar source check

    March 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter

About This Product

Winged infusion needles are used to access a vein or subcutaneous space for injections. In this recall they are used to temporarily expand a tissue expander by percutaneous injection of air or fluids.

Why This Is Dangerous

A dull or blunt needle tip may require more force to insert or advance, increasing tissue trauma. The needle can also break during use, posing injury risk to patients and clinicians.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall covers 105,550 units distributed worldwide, including TX and Costa Rica. Immediate cessation of use is required. No injuries are reported in the data provided, but the hazard is serious for medical procedures.

Practical Guidance

How to identify if yours is affected

  1. Verify Model/Catalog Number 7B3050 on device packaging or labels
  2. Review expiration dates: 30APR2032, 30JUN2032, 31MAY2032, 31JUL2032, 30SEP2032, 31AUG2032
  3. Confirm distribution region includes TX and Costa Rica

Where to find product info

FDA enforcement report Z-1481-2026 and the manufacturer’s recall notice

What timeline to expect

Refunds or replacements timelines are not specified in the provided data; typical processing may take several weeks.

If the manufacturer is unresponsive

  • Document all outreach attempts to the manufacturer.
  • Escalate to FDA consumer complaints or local regulatory authorities if there is no response.
  • Consider legal counsel for unresolved issues or injuries.

How to prevent similar issues

  • Check model and lot numbers before using any device
  • Maintain a record of recalls and disposal instructions
  • Purchase from authorized distributors
  • Inspect packaging for integrity before use
  • Verify expiration dates prior to clinical use

Documentation advice

Keep the recall notice, packaging, serial and lot codes, photos, and all correspondence with the manufacturer for records.

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Key Facts

  • Worldwide distribution including TX and Costa Rica

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
LACERATION

Product Details

Model Numbers
7B3050
Affected States
ALL
Report Date
March 11, 2026
Recall Status
ACTIVE

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