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, PREGNANT, 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: 490367, Primary UDI-DI: 04046964669903, Unit of Dose UDI-DI: 04046964669798
- 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 medications via IV lines in clinical and facility settings. This recall involves gravity sets and pump-compatible sets used with BBraun Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
Why This Is Dangerous
Backflow from secondary IV containers into primary containers can occur with this set. The occlusion issue can prevent proper priming, risking incorrect dosing or medication delivery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to stop using affected lots and replace sets. The potential for incorrect dosing or contamination could affect patient safety and care delivery.
Practical Guidance
How to identify if yours is affected
- Inspect for Catalog Number 490367
- Check Primary UDI-DI 04046964669903
- Check Unit of Dose UDI-DI 04046964669798
- Confirm distribution country and date range on labeling
Where to find product info
Product labeling and the FDA recall page linked in the article.
What timeline to expect
Refunds or replacements are not specified in the recall notice. Expect updates from the manufacturer; typical timelines for medical-device recalls can
If the manufacturer is unresponsive
- Document all communications with the manufacturer and healthcare facilities
- File a complaint with the FDA if in the United States
- Consult hospital risk management if used in clinical settings
How to prevent similar issues
- Ensure devices have backflow prevention features and anti-occlusion design before use
- Verify UDIs and catalog numbers on packaging
- Follow manufacturer instructions during use and setup
- Maintain a rapid response plan for recall events in healthcare facilities
Documentation advice
Keep the recall letter, packaging photos showing Catalog Number and UDIs, and all correspondence with the manufacturer
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Product Details
Catalog Number: 490367 Primary UDI-DI: 04046964669903 Unit of Dose UDI-DI: 04046964669798 Sold worldwide (US, Canada, Germany, Guatemala, Singapore) Recall date: 2025-10-29 Quantity: 6,768 units Brand: B Braun Medical Product: IV Administration Set Price: Not disclosed
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 6,768 units affected worldwide
- Unit of Dose UDI-DI: 04046964669798
- Hazard: backflow and occlusion risk
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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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