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
- Catalog Number 490241, Catalog Number 490298, Catalog Number 490360
- Sizes
- 107 in, 116 in, 119 in
- 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
IV administration sets are used to deliver medications and fluids through IV lines. These sets connect to primary and secondary containers and are used with infusion pumps in hospitals and clinics.
Why This Is Dangerous
Backflow can mix medication between containers, potentially altering dosing. An occlusion can prevent priming, disrupting flow and delivery.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The risk affects patients receiving IV medications. Immediate action is required to prevent potential dosing errors and interruption of therapy.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers on packaging: 490241, 490298, 490360.
- Note device length: 107 in, 116 in, 119 in.
Where to find product info
UDI-DI numbers and catalog numbers are on the device packaging and product labeling.
What timeline to expect
4-8 weeks for refunds or replacements once processed by the manufacturer.
If the manufacturer is unresponsive
- Engage hospital procurement and clinical engineering teams.
- File a complaint with the FDA if the manufacturer is not responsive.
How to prevent similar issues
- Verify model numbers before use.
- Use only manufacturer-approved devices with compatible pumps.
- Maintain an updated recall log in your facility.
Documentation advice
Keep the recall notification, photos of the affected product, and copies of all communications with the manufacturer.
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Product Details
Catalog numbers: 490241, 490298, 490360. Primary UDI-DIs: 04046964716447, 04046964716829, 04046964642609. Sold worldwide through multiple healthcare distributors. US and international distribution to Canada, Germany, Guatemala, and Singapore. Price: Unknown. Sold date: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- UDIs correspond to 107 in, 116 in, and 119 in lengths
- Worldwide distribution; US and international to Canada, Germany, Guatemala, Singapore
- Hazard: backflow of medication and inability to prime
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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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