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
- Catalog Number: 490070, Primary UDI-DI: 04046964301582, Unit of Dose UDI-DI: 04046964301575
- 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 in hospitals and clinics. They connect to IV bags or containers and may be used with gravity or infusion pumps.
Why This Is Dangerous
Backflow from piggyback containers into primary containers and failure to prime can lead to incorrect dosing or interrupted IV therapy.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Facilities must identify affected lots, halt use, and replace or manage inventory to avoid patient safety risks. No injuries have been reported yet.
Practical Guidance
How to identify if yours is affected
- Check packaging and labeling for Catalog Number 490070.
- Verify Primary UDI-DI 04046964301582 and Unit of Dose UDI-DI 04046964301575.
- Note the expiration language: Earliest Exp of Component or 60 months.
Where to find product info
Review labeling on device and the FDA recall page linked in the notice.
What timeline to expect
Not specified by recall; follow manufacturer instructions for replacement or disposal.
If the manufacturer is unresponsive
- Document all communications
- Escalate to hospital risk management
- Consider filing a recall report with FDA if issues persist.
How to prevent similar issues
- Always verify device labeling before use
- Cross-check UDI with inventory records
- Ensure pumps and piggyback systems are compatible with sets before reuse.
Documentation advice
Keep copy of recall notice, photos of labels, UDI numbers, and all correspondence with the manufacturer.
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Product Details
Catalog Number: 490070 Primary UDI-DI: 04046964301582 Unit of Dose UDI-DI: 04046964301575 Description: IV Administration Set used in gravity IV administration sets and pump administration sets for Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump Sold distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore) Recall Date: 2025-10-29 Status: Active Quantity: 9,500 units Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI: 04046964301575
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Safety Guide
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