HIGH

B. Braun Medical 21GA Winged Infusion Set 7M2802 Recalled 51,300 Units (2026)

B. Braun Medical recalls 51,300 units of its 21GA Winged Infusion Set, model 7M2802, distributed worldwide including Texas and Costa Rica. The device’s needle tip can be dull or break, making advancement difficult. Stop using the device immediately and contact the manufacturer or your healthcare provider for instructions.

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

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

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About This Product

The 21GA Winged Infusion Set is used for subcutaneous procedures to facilitate percutaneous injections in tissue expansion contexts. It is typically used by healthcare providers in clinical settings.

Why This Is Dangerous

A dull or blunt needle tip can impede safe needle advancement and may break, increasing the risk of tissue injury or improper delivery.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

The recall affects a sizable batch of devices used in medical settings. Consumers and healthcare providers should halt use immediately to avoid injury and follow the manufacturer’s recall instructions.

Practical Guidance

How to identify if yours is affected

  1. Identify Model 7M2802 on the device label
  2. Check for Lot numbers 0062003864, 0062004133, 0062006454, 0062028929, 0062037141, 0062037691
  3. Check expiration dates up to 30SEP2032
  4. Note that distribution includes worldwide markets and US Texas; Costa Rica noted

Where to find product info

Refer to the FDA enforcement report at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1483-2026

What timeline to expect

The notice does not specify a refund or replacement timeline. Follow manufacturer instructions for remedy processing.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer
  • Escalate to the hospital or clinic if the device was used in patient care
  • Contact FDA or relevant authorities if the supplier is unresponsive

How to prevent similar issues

  • Verify lot numbers and expiration dates before use of infusion sets
  • Purchase from reputable suppliers with recall check processes
  • Maintain an updated recall monitoring routine for medical devices

Documentation advice

Keep the recall letter, note the device model and lot numbers, log dates of contact with manufacturer, preserve any unused devices and packaging for reference

Product Details

Model: 7M2802. Sold worldwide, with US distribution in Texas and in Costa Rica. Price not disclosed. Quantity: 51,300 units. Lot numbers and expirations include: 0062003864 (EXP 30APR2032), 0062004133 (EXP 30JUN2032), 0062006454 (EXP 31JUL2032), 0062028929 (EXP 31AUG2032), 0062037141 (EXP 30SEP2032), 0062037691 (EXP 30SEP2032).

Key Facts

  • 51,300 units recalled
  • Model 7M2802
  • Worldwide distribution; US Texas and Costa Rica noted
  • Lot numbers 0062003864, 0062004133, 0062006454, 0062028929, 0062037141, 0062037691
  • Expirations up to 30SEP2032
  • Needle tip may be dull, difficult to advance, or break

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
LACERATIONOTHER

Product Details

Model Numbers
7M2802
Affected States
ALL
Report Date
March 11, 2026
Recall Status
ACTIVE

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