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 (IV Administration Set for gravity and pump use)
- Model numbers
- Catalog Number: 490476, Primary UDI-DI: 04046964958953, Unit of Dose UDI-DI: 04046964958946
- 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
The product is an anesthesia IV set used in gravity and pump-based IV administration with BBMI pumps. It is used in hospital settings to deliver medications and fluids intravenously.
Why This Is Dangerous
Backflow from piggyback to primary IV containers and occlusion during priming can lead to incorrect dosing or lack of delivery of meds.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided information.
Real-World Impact
Hospitals and clinics may need to quarantine affected lots and replace devices to ensure safe IV administration, potentially affecting operations and procurement timelines.
Practical Guidance
How to identify if yours is affected
- Locate Catalog Number 490476 on packaging or labeling.
- Record Primary UDI-DI 04046964958953 and Unit of Dose UDI-DI 04046964958946.
- Confirm the device is listed in the recall notice.
Where to find product info
Recall notice and FDA enforcement page provide identifiers and instructions.
What timeline to expect
Recall processing and replacements are managed by the manufacturer; timelines vary by facility and inventory levels.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- Document all correspondence and keep copies of recall notices.
- Consider contacting regulatory agencies if manufacturer support is slow.
How to prevent similar issues
- Verify UDI codes during purchasing and inventory checks.
- In future purchases, ensure supplier recall status is reviewed before acceptance.
- Keep a centralized log of all recall notices and actions.
Documentation advice
Keep the recall notice, hospital communications, and replacement records. Photograph labeling and UDI-DI cards for audit.
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Product Details
Catalog Number: 490476; Primary UDI-DI: 04046964958953; Unit of Dose UDI-DI: 04046964958946. Distribution: Worldwide distribution including US, Canada, Germany, Guatemala, and Singapore. Quantity: 19,320 units. Sold through healthcare facilities to hospitals and clinics.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 19,320 units
- Unit of Dose UDI-DI: 04046964958946
- Recall status: Active
- Hazard: backflow and occlusion risk
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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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