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
- 490400
- 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 IV administration set is used in hospitals to deliver medications and fluids. It supports both gravity-driven and pump-assisted infusion with secondary (piggyback) containers.
Why This Is Dangerous
Backflow from secondary to primary IV lines can alter delivery of medications. Occlusion can prevent priming, delaying or altering intended dosing.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Hospitals may need to halt uses of affected sets, replace stock, and review infusion protocols to prevent dosing errors.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490400 on the device or packaging.
- Verify Primary UDI-DI 04046964761393.
- Verify Unit of Dose UDI-DI 04046964761386.
- Confirm distribution and recall status with the facility's risk management.
Where to find product info
Identifiers are printed on the device label and packaging. The recall notice provides catalog and UDI details.
What timeline to expect
Refund or replacement processing may take 4-8 weeks after submission of a claim.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a complaint with the appropriate health authority if necessary.
- Consult hospital risk management for escalation.
How to prevent similar issues
- Verify the catalog and UDI codes before use during procurement.
- Establish recall monitoring with suppliers and distributors.
- Train clinical staff to stop use of recalled devices immediately.
Documentation advice
Keep the recall notice, purchase records, serial/UDI data, and all correspondence with the manufacturer.
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Product Details
Catalog Number: 490400; Primary UDI-DI: 04046964761393; Unit of Dose UDI-DI: 04046964761386; Where sold: Worldwide distribution; US distribution and international distribution to Canada, Germany, Guatemala, and Singapore; When sold: Unknown; Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 19,104 units recalled worldwide
- Catalog number 490400; Primary UDI-DI 04046964761393; Unit of Dose UDI-DI 04046964761386
- Hazard: backflow between IV containers and occlusion that affects priming
- Recall status: ACTIVE as of 2025-12-03
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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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