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
- Catalog Number 490234, Primary UDI-DI 04046964716362, Unit of Dose UDI-DI 04046964716355
- 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 attaches to gravity IV administration sets or pump administration sets used with BBMI infusion pumps. It is intended to deliver medications and fluids from IV bags to patients.
Why This Is Dangerous
Backflow from secondary IV containers into primary containers can occur due to design issues. The device may also fail to prime, potentially impacting dose delivery.
Industry Context
This recall is not stated as part of a broader industry pattern in the provided data.
Real-World Impact
Healthcare facilities may need to inspect inventory and remove affected lots. Hospitals could face downtime to replace the device and adjust infusion workflows.
Practical Guidance
How to identify if yours is affected
- Check packaging for Catalog Number 490234
- Verify Primary UDI-DI 04046964716362 on the device packaging
- Verify Unit of Dose UDI-DI 04046964716355
- Do not use if catalog number or UDIs do not match
Where to find product info
Recall details and identifiers are on the FDA enforcement page and the manufacturer’s recall notice
What timeline to expect
Remedies, refunds, or replacements typically take 4-6 weeks
If the manufacturer is unresponsive
- File a complaint with FDA recall portal
- Contact hospital's compliance department
- Consult the distributor or medical device representative
How to prevent similar issues
- Check packaging for catalog number and UDIs before use
- Review IV extension set compatibility with equipment
- Maintain a supplier-approved inventory and recall readiness
Documentation advice
Keep recall notice, photos of the product, batch numbers, and all correspondence with the manufacturer
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Product Details
Catalog Number: 490234. Primary UDI-DI: 04046964716362. Unit of Dose UDI-DI: 04046964716355. Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 27,480 units. Brand: B. Braun Medical.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964716355
- Distribution worldwide including US, Canada, Germany, Guatemala, and Singapore
- 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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