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 (gravity and pump)
- Model numbers
- 470005, 04046964297199, 04046964297182
- 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 via IV lines. They connect primary IV routes to secondary piggyback containers and are used in hospitals and clinics.
Why This Is Dangerous
This recall concerns a risk of backflow from a piggyback container into the primary IV line and an occlusion that prevents priming, potentially affecting medication delivery.
Industry Context
This recall is not stated as part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- Check packaging for Catalog Number 470005
- Verify Primary UDI-DI 04046964297199
- Verify Unit of Dose UDI-DI 04046964297182
- If matched, stop use immediately
- Contact the manufacturer for refund/replacement details
Where to find product info
Refer to the recall page and FDA enforcement report for official identifiers and instructions
What timeline to expect
Refunds or replacements timelines are not specified in the recall notice
If the manufacturer is unresponsive
- Escalate with hospital procurement or regulatory body
- Document all communications
- Consider seeking guidance from patient safety offices
How to prevent similar issues
- For future purchases, verify UDI codes on-label and ensure recall status is checked before use
- Only purchase from authorized medical distributors
- Maintain a recall monitoring routine for medical devices
Documentation advice
Keep the recall notice, packing, and any incident reports; document lot numbers and UDI codes for internal records
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Product Details
Catalog Number: 470005 Primary UDI-DI: 04046964297199 Unit of Dose UDI-DI: 04046964297182 Quantity: 29,900 units Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore) Sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964297182
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Safety Guide
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