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
- 490315, 490331, 490376
- 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 fluids and medications in clinical settings. This recall involves sets used with gravity and pump infusion systems.
Why This Is Dangerous
The defect can allow backflow from piggyback containers into the primary IV line and may prevent proper priming due to occlusion, risking incorrect dosing or contamination.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to substitute sets quickly to avoid treatment delays. Consumers could face delays in care if replacements are not readily available.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers 490315, 490331, 490376.
Where to find product info
Product identifiers are printed on the packaging and on the IV set itself.
What timeline to expect
Refunds/replacements follow the manufacturer’s recall process. Processing times vary by supplier.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- If the company is slow to respond, contact FDA for guidance.
- Consider filing a consumer complaint with CPSC if appropriate.
How to prevent similar issues
- When buying IV sets, verify FDA recall status and confirm UDI-DI matches the product.
- Choose suppliers with clear recall management.
- Keep a record of recall notifications for risk management.
Documentation advice
Keep the recall notice, purchase receipts, serial numbers/CDs, photos of the product, and any correspondence with the manufacturer.
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Product Details
Catalog Numbers: 490315, 490331, 490376. Worldwide distribution including US and international distribution to Canada, Germany, Guatemala, and Singapore. Sold: Unknown. Recall date: 2025-10-29. Quantity: 11,832 units. Price: Unknown. US/International distribution: Yes. Model numbers and related UDIs: - Catalog Number 490315. Primary UDI-DI: 04046964527173. Unit of Dose UDI-DI: 04046964525612. - Catalog Number 490331. Primary UDI-DI: 04046964541148. Unit of Dose UDI-DI: 04046964541131. - Catalog Number 490376. Primary UDI-DI: 04046964718182. Unit of Dose UDI-DI: 04046964718175.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Hazard: backflow and occlusion
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Safety Guide
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