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
- 490487, 04046955086856, 04046955086849
- 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 used to deliver fluids and medications via IV lines. They connect to IV bags or containers and may be used with gravity or pump-driven systems.
Why This Is Dangerous
Backflow into primary containers or occlusion can disrupt dosing and advance the risk of medication errors or incomplete infusion.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The risk is significant for clinical accuracy and patient safety. Hospitals will need to remove affected inventory and coordinate replacements.
Practical Guidance
How to identify if yours is affected
- Check catalog number 490487 on the device or packaging.
- Check Primary UDI-DI 04046955086856 on the label.
- Check Unit of Dose UDI-DI 04046955086849.
Where to find product info
Refer to the FDA enforcement recall page linked in the notice for detailed instructions and refunds.
What timeline to expect
4-8 weeks for refunds or replacements typical.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Escalate to hospital supply chain management and file a recall notice with appropriate regulatory bodies if needed.
How to prevent similar issues
- Verify device compatibility with pumps and IV systems before use.
- Purchase only from authorized medical suppliers.
- Regularly review recall notices from FDA and manufacturer communications.
Documentation advice
Keep the recall notice, product packaging, model numbers, UDIs, and all correspondence with the manufacturer for records.
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Product Details
Catalog Number: 490487 Primary UDI-DI: 04046955086856 Unit of Dose UDI-DI: 04046955086849 Quantity recalled: 23,160 units Sold worldwide, including US, Canada, Germany, Guatemala, Singapore Recall date: 2025-10-29 Status: ACTIVE Brand: B Braun Medical Product: IV Administration Set used in gravity and pump administration with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955086849
- Global distribution including US, Canada, Germany, Guatemala, Singapore
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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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