HIGHFDA DEVICE

B. Braun Medical Recalls 21GA Winged Infusion Set (7A3842) 21,000 Units (2026)

B. Braun Medical is recalling 21,000 21GA Winged Infusion Sets (Single Pack) distributed worldwide, including Texas and Costa Rica, catalog 7A3842. The needle tip can be dull or blunt, may be difficult to advance, or break. Clinicians and patients should stop using the device and await manufacturer 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
Unknown
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 Set
Model numbers
7A3842, 4046964338434, 4046964338410, 0062004706, 0062005799, 0062006415, 0062006416, 0062023397 +1 more
Sold at
Unknown
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 sets are used to access veins and deliver injections or draw blood. In this recall, the devices are used to subcutaneously expand an implanted tissue expander via percutaneous injection of air or fluids in medical procedures.

Why This Is Dangerous

A dull or blunt needle tip can hinder insertion, require extra force, and may break. Breakage can cause tissue injury or incomplete delivery of intended fluid.

Industry Context

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

Real-World Impact

Hospitals and clinics may need to halt use of affected lots, source replacements, and manage inventory disruption. There may be delays in procedures that rely on these sets.

Practical Guidance

How to identify if yours is affected

  1. Verify Model/Catalog Number 7A3842 on the device label.
  2. Review Expiration Dates: 31MAR2032, 30JUN2032, 31JUL2032.

Where to find product info

Recall notices and manufacturer instructions are available via the FDA enforcement page for Z-1482-2026 and B. Braun Medical’s recall communications.

What timeline to expect

Typically 4-8 weeks for replacement or remediation communications after a recall notice is issued.

If the manufacturer is unresponsive

  • Document all contact attempts with the manufacturer.
  • Escalate to hospital compliance teams and local health authorities if a response is slow.

How to prevent similar issues

  • Verify lot codes and expiration dates before acquiring infusion sets.
  • Source infusion sets from authorized distributors and maintain an updated inventory log.
  • Train staff to pause use when a new recall is announced and follow manufacturer instructions promptly.

Documentation advice

Keep the recall notice, packaging labels, lot numbers, and all correspondence with the manufacturer. Photograph affected lots and maintain a log of actions taken.

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Product Details

Model/Catalog Number: 7A3842; Primary-DI: 4046964338434; Unit of Use-DI: 4046964338410; Lot numbers: 0062004706, 0062005799, 0062006415, 0062006416, 0062023397, 0062024887; Exp dates: 31MAR2032, 30JUN2032, 31JUL2032; Quantity: 21000 units; Distribution: Worldwide, including US (TX) and Costa Rica; Sold at: Unknown; Price: Unknown.

Key Facts

  • Model/Catalog Number 7A3842
  • Expirations 31MAR2032, 30JUN2032, 31JUL2032
  • Hazard: dull/blunt needle tip that may 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
7A3842
4046964338434
4046964338410
0062004706
0062005799
+4 more
Affected States
ALL
Report Date
March 11, 2026
Recall Status
ACTIVE

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