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
- 490202, 04046964303845, 04046964303838
- 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 extension set connects IV lines from a primary infusion pump to the patient, allowing administration of IV medications. This particular product supports gravity IV and pump-assisted administration and uses a 57-inch Ultraport line.
Why This Is Dangerous
Backflow from piggyback to primary IV containers can contaminate the IV line. An occlusion can prevent proper priming of the line, risking improper dosing.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must halt use of the affected lots. The recall involves 13,600 units distributed worldwide, with potential for patient harm if not addressed promptly.
Practical Guidance
How to identify if yours is affected
- Check packaging for Catalog Number 490202
- Verify Primary UDI-DI 04046964303845
- Verify Unit of Dose UDI-DI 04046964303838
- Confirm 57-inch Ultraport extension set configuration
Where to find product info
Labeling on the packaging and product documentation; recall notice and FDA page
What timeline to expect
Refund or replacement processing typically 4-6 weeks after verification
If the manufacturer is unresponsive
- Escalate with hospital procurement or supplier
- File a formal complaint with the FDA recall process if needed
How to prevent similar issues
- Verify catalog number and UDI codes before procurement
- Establish a recall protocol with suppliers and distributors
- Prefer devices with explicit backflow prevention features
Documentation advice
Save recall notification, take photos of labels, maintain shipment records and correspondence with the manufacturer
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Product Details
Catalog Number: 490202; Description: EXT SET W/ B/C VLV, ULTRAPORT, 57 IN.; Primary UDI-DI: 04046964303845; Unit of Dose UDI-DI: 04046964303838; Quantity recalled: 13,600 units; Regions distributed: Worldwide, including US, Canada, Germany, Guatemala, Singapore; Manufacturer: B Braun Medical Inc; Recall Date: 2025-10-29; Status: Active
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964303838
- Hazard: backflow and occlusion
- 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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