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
- Model numbers
- 490301
- 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 IV administration set is used to deliver IV medications through gravity or pump-assisted systems in clinical settings. It connects to IV containers and pumps to control fluid flow.
Why This Is Dangerous
A backflow path from secondary piggyback lines into the primary IV line, plus an occlusion that prevents priming, could compromise medication delivery and patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics may need to replace affected lots, re-train staff on priming procedures, and review pump configurations to prevent interruptions in therapy.
Practical Guidance
How to identify if yours is affected
- Identify catalog number 490301 on the IV set
- Verify UDI-DI 04046964716867 (primary) and 04046964716850 (unit of dose)
- Confirm expiration date is 36 months from Start Date
- Check distribution records to see if your facility received the affected units
Where to find product info
Recall details and instructions are available on the FDA enforcement page linked in the notice
What timeline to expect
Refund or replacement information will be provided by the manufacturer through the recall notification; expect 4-6 weeks for processing
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- Escalate to hospital risk management or CPSC if you cannot obtain replacement guidance
- Consider notifying regulatory authorities if replacements are not provided in a timely manner
How to prevent similar issues
- Verify catalog numbers and UDIs before deploying IV sets
- Prefer manufacturers with clear recall processes and online recall portals
- Institute a filtering process to separate recalled stock from usable stock in inventory
Documentation advice
Keep a copy of the recall notice, inventory records showing affected lots, correspondence with BBraun, and photographs of the affected packaging.
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Product Details
Catalog Number 490301. Primary UDI-DI 04046964716867. Unit of Dose UDI-DI 04046964716850. Expiration Date: 36 months from Start Date. Sold worldwide with US and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 31,392 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964716850
- Expiration Date: 36 months from Start Date
- Worldwide distribution; US, Canada, Germany, Guatemala, Singapore
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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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