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
- Blood Administration Set
- Model numbers
- Catalog Number: 490355, Primary UDI-DI: 04046964616013, Unit of Dose UDI-DI: 04046964616006
- 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
Blood administration sets are used to deliver blood products or IV medications via gravity or pump systems. They connect to IV bags or bottles and routes to the patient through tubing and a Y-site. These sets are used in hospitals and clinics.
Why This Is Dangerous
Backflow can cause unintended administration of medications and compromised priming, risking incorrect dosing or contamination.
Industry Context
This recall is not stated as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may need to quarantine affected inventory and switch to replacement sets, impacting workflow and potentially delaying treatments.
Practical Guidance
How to identify if yours is affected
- Locate catalog number 490355 on the packaging or tubing set.
- Verify Primary UDI-DI 04046964616013 and Unit of Dose UDI-DI 04046964616006.
- Check the recall notice for replacement or refund instructions.
Where to find product info
Recall notice and instructions available at the FDA enforcement page linked in the recall notice.
What timeline to expect
Replacement or refund processing times will be provided by the manufacturer; typical timelines vary by facility.
If the manufacturer is unresponsive
- Document all requests and responses with the manufacturer.
- Escalate to hospital procurement or regulatory compliance if there is no timely reply.
How to prevent similar issues
- When purchasing blood administration sets, verify recalls and model numbers.
- Use devices from manufacturers with robust post-market surveillance.
- Keep a centralized log of recalled items and quarantine affected stock.
Documentation advice
Keep the recall notice, catalog number, UDIs, purchase records, and all correspondence with the manufacturer for records.
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Product Details
Catalog Number: 490355. Distribution: Worldwide, including United States, Canada, Germany, Guatemala, and Singapore. Sold since: Unknown. Price: Unknown. Primary UDI-DI: 04046964616013. Unit of Dose UDI-DI: 04046964616006.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 24,624 total units recalled
- Unit of Dose UDI-DI 04046964616006
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Hazard: backflow risk and occlusion; immediate stop-use
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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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