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: 490329, Primary UDI-DI: 04046964541100, Unit of Dose UDI-DI: 04046964541094
- 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 sets are used to deliver intravenous medication through gravity or pump systems. They are critical in hospital settings for treating patients with a variety of conditions. Healthcare providers use these sets to ensure accurate dosing of medications.
Why This Is Dangerous
The IV administration sets may allow backflow of medication from secondary containers into primary IV containers. This backflow can lead to administration of incorrect dosages, potentially harming patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare facilities and patients may face safety risks due to the potential for medication errors. Immediate cessation of use of these sets is necessary to mitigate these risks.
Practical Guidance
How to identify if yours is affected
- Check your IV administration set for the catalog number: 490329.
- Look for the UDI-DI numbers for further identification.
- Contact your healthcare provider for assistance in verifying if your set is affected.
Where to find product info
The catalog number and UDI-DI numbers are typically found on the product packaging or accompanying documentation.
What timeline to expect
Expect processing for refunds or replacements to take 4-6 weeks from the time of contact with the manufacturer.
If the manufacturer is unresponsive
- Document all communications with the manufacturer or healthcare provider.
- Consider escalating the issue through consumer advocacy groups if no response is received.
How to prevent similar issues
- Look for IV administration sets that comply with FDA safety standards.
- Read product reviews and reports of safety issues before purchasing.
- Purchase from reputable suppliers with a history of safety compliance.
Documentation advice
Keep records of your purchase, any medical advice received, and communications regarding the recall for future reference.
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Product Details
Product: IV Administration Set Catalog Number: 490329 UDI-DI: 04046964541100, 04046964541094 Quantity Recalled: 18,984 units Distribution: Worldwide, including the US, Canada, Germany, Guatemala, and Singapore
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Potential for backflow of medication
- Worldwide distribution including US and Canada
- No reported injuries or incidents
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Safety Guide
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