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: 352646, Primary UDI-DI: 04046955626946, Unit of Dose UDI-DI: 04046955626939
- 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
SafeDAY sets are used to administer IV therapy in gravity and pump-driven systems. They are utilized with Infusomat Space Large Volume Pumps, Outlook Pump, and Vista Basic Pump.
Why This Is Dangerous
Backflow from secondary to primary IV containers and occlusion can lead to incorrect dosing or interrupted therapy.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The recall affects more than half a million units; facilities must halt use to prevent potential medication backflow.
Practical Guidance
How to identify if yours is affected
- Verify Catalog Number 352646 on device label.
- Check Primary UDI-DI 04046955626946 and Unit of Dose UDI-DI 04046955626939.
- Review expiration date relative to 36 months from Start Date.
Where to find product info
Recall notice via FDA enforcement portal and BBraun Medical communications.
What timeline to expect
4-8 weeks for refund or replacement processes once initiated by the manufacturer.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a complaint with FDA if manufacturers do not respond
- Consult legal counsel if patient exposure occurred
How to prevent similar issues
- Verify catalog numbers and UDIs before procurement
- Use only approved suppliers
- Maintain an active recall log for all IV sets and pumps
Documentation advice
Keep recall letter, inventory lists, photos of labels, and all correspondence with the manufacturer
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Product Details
Catalog Number: 352646. Primary UDI-DI: 04046955626946. Unit of Dose UDI-DI: 04046955626939. Expiration Date: 36 months from Start Date. Distribution: Worldwide, including the US, Canada, Germany, Guatemala and Singapore. Quantity: 554,015 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Unit of Dose UDI-DI 04046955626939
- Expiration: 36 months from Start Date
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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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