Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- BBraun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- BBraun Medical
- Product type
- IV Administration Set
- Model numbers
- Catalog Number 490491, Primary UDI-DI 04046955086931, Unit of Dose UDI-DI 04046955086924
- Sold at
- Unknown
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
This IV administration set is used to deliver medications via gravity or through IV pumps in healthcare settings.
Why This Is Dangerous
Backflow from secondary to primary IV containers can alter dosing. Inability to prime can cause incomplete administration.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
No injuries reported yet. Healthcare facilities will need to replace affected sets and monitor for potential dosing issues during IV administration.
Practical Guidance
How to identify if yours is affected
- Locate Catalog Number on the device or packaging: 490491.
- Verify Primary UDI-DI: 04046955086931.
- Verify Unit of Dose UDI-DI: 04046955086924.
- Check expiration date for earliest expiry up to 36 months from manufacture.
Where to find product info
UDI labels are typically printed on packaging and the device itself. Refer to FDA recall page for official identifiers.
What timeline to expect
Manufacturer-led remediation will determine replacement or refunds; expect 4-8 weeks for processing after request.
If the manufacturer is unresponsive
- File a complaint with the FDA if the company is nonresponsive.
- Document all communications and dates.
- Consult hospital risk management for escalation.
How to prevent similar issues
- When purchasing IV administration sets, verify UDI-DI and catalog numbers against the recall list.
- Choose suppliers with current recall status and clear recall processes.
- Ensure pumps are compatible with the IV set.
Documentation advice
Keep recall notification, purchase records, Photos of the device, serials/UDI, and correspondence with manufacturer.
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Product Details
Product: IV Administration Set used in gravity and pump administration with BBraun Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Catalog Number: 490491. Primary UDI-DI: 04046955086931. Unit of Dose UDI-DI: 04046955086924. Distribution: Worldwide including US, Canada, Germany, Guatemala, Singapore. Quantity: 960 units. Hazard: backflow from secondary (piggyback) containers into primary containers and inability to prime.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Unit of Dose UDI-DI 04046955086924
- Expiration: earliest expiry date of component or 36 months
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Safety Guide
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