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: 490242; Primary UDI-DI: 04046964716461; Unit of Dose UDI-DI: 04046964716454, Catalog Number: 490311; Primary UDI-DI: 04046964539688; Unit of Dose UDI-DI: 04046964525629, Catalog Number: 490353; Primary UDI-DI: 04046964602368; Unit of Dose UDI-DI: 04046964602351
- 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 through a patient’s IV line. They connect to piggyback and primary IV containers and include a drip chamber and connectors. These devices are common in hospitals and clinics.
Why This Is Dangerous
Backflow from a secondary piggyback container into the primary line can contaminate or alter the dose. The inability to prime creates the risk that the line will not deliver the intended fluid or medication.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
The recall affects a large quantity of devices used daily in patient care. Hospitals may need to halt use of affected lots and coordinate replacements, potentially impacting treatment schedules and supply chains.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers 490242, 490311, 490353
- Confirm devices were used with BBMI Infusomat Space, Outlook Pump, or Vista Basic Pump
- If matched, quarantine devices and stop use
Where to find product info
Identify packaging labels and device documentation for catalog numbers and UDIs. Refer to the FDA recall page for guidance.
What timeline to expect
Remediation timelines vary by institution. Replacement units and instructions are typically coordinated within 4-8 weeks.
If the manufacturer is unresponsive
- Escalate to hospital supply chain management and biomedical engineering
- Contact the manufacturer’s recall line and your procurement channel
- If needed, file a report with CPSC per local requirements
How to prevent similar issues
- Verify device catalog numbers and UDIs before installation
- Use only approved suppliers and distributors
- Check recalls for IV sets before stocking supplies
- Keep up-to-date with manufacturer recall notifications
Documentation advice
Document recall notice, catalog numbers, and UDIs in asset-tracking systems. Save correspondence with the manufacturer. Photograph affected packaging and keep samples if allowed.
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Product Details
Catalog Numbers: 490242; 490311; 490353. Primary UDI-DI: 04046964716461; Unit of Dose UDI-DI: 04046964716454. Catalog Number 490311: Primary UDI-DI 04046964539688; Unit of Dose UDI-DI 04046964525629. Catalog Number 490353: Primary UDI-DI 04046964602368; Unit of Dose UDI-DI 04046964602351. Distribution: Worldwide, including US, Canada, Germany, Guatemala, and Singapore. Recall Date: 2025-10-29. Quantity: 129,480 units. Sold to healthcare facilities worldwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Three catalog numbers: 490242, 490311, 490353
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Recall date 2025-10-29; Status ACTIVE
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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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