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
- 490225, 04046964304248, 04046964304231
- 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
This product is an IV administration set used in gravity IV administration and pump-based infusion with BBraun equipment. It is designed to deliver medications through IV lines in clinical settings.
Why This Is Dangerous
A backflow risk can transfer medication from secondary lines into primary lines, and occlusion may prevent priming. This can disrupt accurate dosing and impede delivery of IV therapies.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must assess inventory and divert affected sets from use. Facilities may need to replace sets to prevent dosing errors and treatment delays.
Practical Guidance
How to identify if yours is affected
- Check catalog number 490225 on the device label
- Look for Primary UDI-DI 04046964304248
- Look for Unit of Dose UDI-DI 04046964304231
- Verify expiration date is valid (Earliest Exp of Component or 36 months)
- Confirm whether the device you have matches the recall details
Where to find product info
Labels on the IV set packaging will display catalog and UDI numbers. Official recall notice and FDA enforcement page provide guidance.
What timeline to expect
Refunds or replacements, if offered, typically follow the manufacturer’s recall process which may take several weeks.
If the manufacturer is unresponsive
- Escalate to hospital supply chain management
- File a report with the FDA recall process if needed
- Contact the manufacturer directly for remediation options
How to prevent similar issues
- Screen inventory against recall details before use
- Maintain updated recall lists for IV administration sets
- Verify UDI numbers during purchasing and receiving
Documentation advice
Keep the recall notice, document lot/catalog numbers, take photos of labels, record dates and correspondence with supplier
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Product Details
Catalog Number: 490225 Primary UDI-DI: 04046964304248 Unit of Dose UDI-DI: 04046964304231 Expiration: Earliest Exp of Component or 36 months Distribution: Worldwide distribution including US, Canada, Germany, Guatemala, and Singapore Sold at: Multiple medical distributors (unknown retailers)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964304231
- Expiration: 36 months or earliest expiration of component
- Worldwide distribution (US, Canada, Germany, Guatemala, Singapore)
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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