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 Extension Set
- Model numbers
- 470183, 04046964719400, 04046964715549
- 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
This extension set is used to connect gravity IV therapy lines and pump-administered lines in hospital settings.
Why This Is Dangerous
Backflow could cause incorrect dosing or contamination of the IV line. Inability to prime may interrupt medication delivery.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals must identify and remove affected extension sets from inventory to protect patient safety. Facilities should follow the manufacturer’s recall instructions to replace or remedy the device.
Practical Guidance
How to identify if yours is affected
- Check the product label for Catalog Number 470183.
- Verify the UDI-DI: 04046964719400.
- Verify the Unit of Dose UDI-DI: 04046964715549.
Where to find product info
Recall notice and FDA enforcement page provide device identification and instructions.
What timeline to expect
Remedy details and replacement or refund timeline will be provided by the manufacturer in the recall communications.
If the manufacturer is unresponsive
- Escalate to facility recall coordinator.
- Contact FDA/regulatory reporting channels if the manufacturer does not respond within a reasonable timeframe.
How to prevent similar issues
- Strengthen inventory controls for IV extension sets.
- Verify supplier certifications and model numbers before purchase.
- Train staff to check Catalog Number and UDI-DI during receiving and during recalls.
Documentation advice
Keep recall notification letters, proof of purchase, and inventory lists; document communications with the manufacturer.
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Product Details
Catalog Number: 470183. Primary UDI-DI: 04046964719400. Unit of Dose UDI-DI: 04046964715549. Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore). Quantity: 32,500 units. Recall Date: 2025-10-29. Status: ACTIVE. Brand: B. Braun Medical.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Recall date 2025-10-29; status ACTIVE
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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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