Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brands
- BB Braun Medical, BB Braun Medical Inc
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, INFANTS
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
- BB Braun Medical, BB Braun Medical Inc
- Product type
- IV Administration Set
- Model numbers
- Catalog Number 490426, Primary UDI-DI: 04046964823503, Unit of Dose UDI-DI: 04046964823497
- 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
IV administration sets are tubing assemblies used to deliver medications and fluids via IV and piggyback systems. They connect to pumps or gravity-fed IV lines to deliver controlled doses.
Why This Is Dangerous
Backflow could cause incorrect dosing or contamination. Occlusion may prevent proper priming and flow.
Industry Context
This recall is not noted as part of a broader industry pattern in the provided data.
Real-World Impact
The recall involves a large quantity and worldwide distribution, emphasizing immediate discontinuation and replacement through manufacturer guidance.
Practical Guidance
How to identify if yours is affected
- Verify Catalog Number 490426 on packaging
- Check UDIs 04046964823503 and 04046964823497 on product labels
- Confirm pump compatibility with Infusomat Space LV Pump, Outlook Pump, and Vista Basic Pump
Where to find product info
FDA enforcement page Z-0681-2026 and BB Braun Medical recall communications
What timeline to expect
Typical recall timelines range from weeks to months for replacement or refund; exact timeframe not provided
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- Submit a formal complaint to FDA if unresolved
- Consider seeking legal advice for prolonged delays
How to prevent similar issues
- Verify catalog numbers and UDIs before use or stocking
- Implement strict procurement checks for IV sets
- Record batch/lot numbers in inventory
- Ensure pumps are compatible with the IV sets being used
Documentation advice
Keep recall letters, UDIs, catalog numbers, purchase records, and correspondence with the manufacturer
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Product Details
Model: Catalog Number 490426. Primary UDI-DI: 04046964823503. Unit of Dose UDI-DI: 04046964823497. Expiration: Earliest Expiration Date of Component or 36 months. Quantity: 63,192 units. Distribution: Worldwide including US, Canada, Germany, Guatemala, Singapore. Brand: B Braun Medical. Product: IV Administration Set used with gravity and pump administration sets for BBMI Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
Reported Incidents
No specific injuries or incidents are detailed in the provided data.
Key Facts
- Worldwide distribution: US, Canada, Germany, Guatemala, Singapore
- High risk: backflow and occlusion potentially affecting IV medication delivery
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Safety Guide
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