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
- 490504, 04046955135738, 04046955135721
- 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 are used to deliver medications and fluids through IV lines, either by gravity or with infusion pumps. This recall concerns a gravity/pump-compatible set labeled 490504.
Why This Is Dangerous
Backflow can deliver medications into incorrect containers or cause contamination. An occlusion can prevent priming, compromising safe administration and delivery of fluids.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and caregivers may need to switch to other IV sets. The recall emphasizes immediate cessation of use and reliance on manufacturer guidance.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number on the device label for 490504
- Inspect UDIs 04046955135738 (Primary) and 04046955135721 (Unit of Dose)
- Verify if your device matches the recalled configuration
- If applicable, cease use and contact the manufacturer for instructions
Where to find product info
UDI-DI numbers and Catalog Number are on device labeling and packaging.
What timeline to expect
4-6 weeks for replacement or remedy processing or guidance from the manufacturer.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Escalate to your hospital risk management or regulatory authority if needed.
- File a report with the appropriate regulatory body if you experience harm.
How to prevent similar issues
- Verify device compatibility with infusion pumps and piggyback operations before use.
- Check UDIs and catalog numbers before accepting shipments.
- Follow all recall communications and document actions taken.
- Consider sourcing from approved suppliers until recall is resolved.
Documentation advice
Keep copies of all recall notices, device labels, UDIs, and correspondence with the manufacturer.
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Product Details
Catalog Number: 490504. Primary UDI-DI: 04046955135738. Unit of Dose UDI-DI: 04046955135721. Sold worldwide including the US, Canada, Germany, Guatemala and Singapore. Sold from unknown date to unknown date. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955135721
- World-wide distribution including US, Canada, Germany, Guatemala, Singapore
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Safety Guide
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