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
- 490062, NF1503 15 DR UNIV SPIKE, INJ SITE, BCV
- 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
IV administration sets deliver IV fluids from a primary container to a patient. They connect to pumps or gravity systems in hospitals.
Why This Is Dangerous
Backflow can cause medication to flow into the wrong container. Inability to prime can result in under- or incorrect dosing.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals must halt use of affected sets to avoid dosing errors. The impact is operational disruption and potential patient safety risk if backflow occurs.
Practical Guidance
How to identify if yours is affected
- Check packaging for NF1503 label and Catalog Number 490062.
- Verify Primary UDI-DI 04046964301445 and Unit of Dose UDI-DI 04046964301438.
- Confirm expiration date is within the listed constraints.
Where to find product info
Look at product packaging, instruction sheets, and the recall page (FDA listing) for UDI and catalog numbers.
What timeline to expect
No processing timeline is provided. Replacements or refunds may follow manufacturer guidance and hospital procurement processes.
If the manufacturer is unresponsive
- Document all outreach attempts to the manufacturer.
- Escalate to hospital compliance or risk management.
- If needed, contact the FDA’s recall program for guidance.
How to prevent similar issues
- Vet new lots against the recall before acceptance.
- Use only sets with current recall status.
- Verify UDI-DI codes prior to use in any patient care setting.
Documentation advice
Keep the recall notice, lot numbers, and correspondence. Photograph labeling and packaging for records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Catalog Number: 490062; Primary UDI-DI: 04046964301445; Unit of Dose UDI-DI: 04046964301438; Expiration Date: Earliest Exp of Component or 60 months; Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore; Quantity: 12,200 units; Model identifiers include NF1503 15 DR UNIV SPIKE, INJ SITE, BCV.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution includes US, Canada, Germany, Guatemala, Singapore
- Catalog Number 490062 and NF1503 15 DR UNIV SPIKE
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.