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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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
- 21GA Winged Infusion Set
- Model numbers
- 7M2802
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 2, 2026
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
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
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
- Identify Model 7M2802 on the device label
- Check expiration dates up to 30SEP2032
- 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
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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
- Worldwide distribution; US Texas and Costa Rica noted
- Expirations up to 30SEP2032
- Needle tip may be dull, difficult to advance, or break
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Safety Guide
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