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
- Anesthesia IV Set for gravity and pump administration
- Model numbers
- Catalog Number: 490472, Primary UDI-DI: 04046964958878, Unit of Dose UDI-DI: 04046964958861
- 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
Anesthesia IV Sets are used to deliver anesthesia agents through gravity or pump systems in hospital settings.
Why This Is Dangerous
Backflow into the primary IV line and occlusion can disrupt correct dosing and patient safety during administration.
Industry Context
This recall is not described as part of a broader industry-wide pattern in the provided data.
Real-World Impact
Hospitals may need to halt use of affected sets and source safe replacements, potentially affecting procedures and scheduling.
Practical Guidance
How to identify if yours is affected
- Locate Catalog Number 490472 on the product label.
- Check Primary UDI-DI 04046964958878 and Unit of Dose UDI-DI 04046964958861.
- Confirm distribution region includes US, Canada, Germany, Guatemala, Singapore.
Where to find product info
Recall notice and FDA enforcement page linked in official communications.
What timeline to expect
Refunds or replacements typically follow 4-6 weeks after verification of affected inventory.
If the manufacturer is unresponsive
- Escalate to hospital compliance or procurement departments.
- File a formal complaint with the vendor and follow internal recall procedures.
How to prevent similar issues
- Verify UDIs during purchasing.
- Work with authorized distributors only.
- Monitor recall notices from FDA and manufacturer for updates.
Documentation advice
Keep copies of recall notices, distribution lists, and correspondence with supplier for records.
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Product Details
Catalog Number: 490472; Primary UDI-DI: 04046964958878; Unit of Dose UDI-DI: 04046964958861. Distribution: Worldwide; US distribution and distribution to Canada, Germany, Guatemala, and Singapore. Sold through hospitals and healthcare distributors. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution to US, Canada, Germany, Guatemala, Singapore
- Stop-use-immediately and follow recall instructions
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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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