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
- Blood Administration Set
- Model numbers
- Catalog Number: 490530, Primary UDI-DI: 04046955203321, Unit of Dose UDI-DI: 04046955203314
- 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
Blood administration sets are used to administer blood via gravity or pump systems. This recall concerns a Y-Type Blood Set used with Infusomat Space Large Volume Pumps and related pump systems.
Why This Is Dangerous
The defect can cause backflow from a secondary IV container into the primary container and may prevent proper priming, creating a potential for incorrect dosing or infusion errors.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to replace the affected sets to maintain patient safety. No injuries are reported in the data provided.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490530
- Check Primary UDI-DI 04046955203321
- Check Unit of Dose UDI-DI 04046955203314
- Confirm the product is used with Infusomat Space Large Volume Pump, Outlook Pump, or Vista Basic Pump
- Verify distribution region includes US, Canada, Germany, Guatemala, or Singapore
Where to find product info
Recall letter from B. Braun Medical; FDA enforcement page for Z-0618-2026
What timeline to expect
Refund or replacement typically 4-8 weeks
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital administration or patient safety officer.
- Consult FDA consumer complaint options if needed.
How to prevent similar issues
- Use IV administration sets with backflow prevention features when purchasing in the future.
- Verify recall status for IV sets prior to purchase.
- Maintain an updated inventory of critical infusion devices.
Documentation advice
Retain recall notice, model numbers, UDI codes, purchase records, and all correspondence with the manufacturer.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Catalog Number: 490530; Primary UDI-DI: 04046955203321; Unit of Dose UDI-DI: 04046955203314; Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore); Quantity: 33,528 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955203314
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Recall date 2025-10-29; Active status
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.