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, 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
- Anesthesia IV Set
- Model numbers
- Catalog Number: 490468, Primary UDI-DI: 04046964958793, Unit of Dose UDI-DI: 04046964958786
- 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
Anesthesia IV Sets are used with gravity or pump-based IV administration systems to deliver medications in hospital settings.
Why This Is Dangerous
A backflow from secondary to primary IV containers could result in incorrect dosing or contamination, and occlusion could prevent priming of the line.
Industry Context
This recall is not a broader industry pattern.
Real-World Impact
Hospitals may need to halt IV therapy using the affected sets, potentially delaying treatments and requiring administrative work to switch to safe alternatives.
Practical Guidance
How to identify if yours is affected
- Review inventory for Catalog Number 490468.
- Check Primary UDI-DI 04046964958793.
- Check Unit of Dose UDI-DI 04046964958786.
Where to find product info
Codes are printed on the product packaging and labels. The FDA recall page provides additional identifiers and instructions.
What timeline to expect
Not specified in the recall notice; replacement timelines vary by institution.
If the manufacturer is unresponsive
- Escalate to the hospital recall contact or procurement officer.
- Document all communications with the manufacturer.
- If needed, file a complaint with the FDA recall portal.
How to prevent similar issues
- Verify device compatibility before procurement.
- Use only unexpired, non-recalled lots for IV administration.
- Establish a recall response protocol with clinicians and suppliers.
Documentation advice
Keep the recall letter, product labels, catalog numbers, UDIs, and all correspondence as part of your incident file.
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Product Details
Catalog Number: 490468. Primary UDI-DI: 04046964958793. Unit of Dose UDI-DI: 04046964958786. Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore). Recall Date: 2025-10-29.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964958786
- Recall status: ACTIVE, HIGH hazard
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Safety Guide
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