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
- 490274, 04046964716621, 04046964716614
- 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 sterile tubing systems used to deliver fluids and medications intravenously. They are used with gravity or pump-based infusion systems in hospitals.
Why This Is Dangerous
Backflow from secondary to primary IV containers can lead to improper dosing. Inability to prime can prevent proper delivery and introduce contamination risk.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The issue can disrupt critical medication delivery and require hospital procurement teams to replace affected lots, potentially affecting patient care and workflow.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490274 on packaging
- Verify Primary UDI-DI 04046964716621
- Verify Unit of Dose UDI-DI 04046964716614
- Note Expiration: Earliest expiry of component or 36 months
Where to find product info
Packaging labeling, FDA recall page, and manufacturer communications
What timeline to expect
Recall process and replacements typically follow hospital procurement timelines; expected 4-8 weeks for resolution
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a complaint with the CPSC if applicable
- Seek guidance directly from B Braun Medical for instructions
- Consult your institution’s procurement for alternatives
How to prevent similar issues
- Verify device labeling before use
- Ensure priming protocols are followed for IV sets
- Maintain up-to-date recall monitoring from FDA/ manufacturer
- Use IV sets with proven backflow prevention features when available
Documentation advice
Keep a copy of recall notices, record recall number Z-0698-2026, save correspondences with the manufacturer, photograph packaging and labeling
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Product Details
Model numbers: Catalog Number 490274. Primary UDI-DI 04046964716621. Unit of Dose UDI-DI 04046964716614. Expiration: Earliest Exp of Component or 36 months. Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity recalled: 98,568 units. Price: Unknown. Sold/distribution: Worldwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964716614
- Worldwide distribution to US, Canada, Germany, Guatemala, Singapore
- Earliest expiry date per component or 36 months
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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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