Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B. Braun Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- IV administration set
- Model numbers
- 352604, NF1251, NF1290
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 29, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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
SAFELINE sets are used in gravity IV administration and pump administration with infusion pumps in healthcare settings.
Why This Is Dangerous
Backflow of medication from secondary piggyback containers into primary IV lines can cause dosing errors or contamination. Occlusion can prevent priming.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may need to switch to alternate IV sets; potential workflow disruption and patient safety risks if used.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers 352604, NF1251, NF1290 on the product label.
- Look for expiration: Earliest Exp of Component or 60 months.
Where to find product info
Identifiers appear on packaging and device labels, including catalog numbers and UDIs.
What timeline to expect
Not specified by the recall notice.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital risk management or local health authority if needed.
How to prevent similar issues
- Verify recall notices before accepting inventory.
- Source IV sets from approved vendors.
- Check for anti-backflow features when selecting IV sets.
Documentation advice
Keep recall notice, photos of labels, purchase documents, and correspondence.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Catalog Numbers: 352604; NF1251; NF1290. Primary UDI-DI: 04046964181870; 04046964187100; 04046964187148. Unit of Dose UDI-DI: 04046964181863; 04046964187094; 04046964187131. Expiration: Earliest Exp of Component or 60 months. Sold Worldwide with US distribution and distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 46,250 units. Brand: B. Braun Medical. Recall Date: 2025-10-29. Recall Number: Z-0713-2026. Status: Active.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Three affected catalog numbers: 352604, NF1251, NF1290
- Hazard: backflow and occlusion risk
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.