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: 490489, Primary UDI-DI: 04046955086894, Unit of Dose UDI-DI: 04046955086887
- 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 deliver medication through IV lines in hospitals and clinics. They come in gravity and pump configurations and connect to infusion pumps such as Infusomat Space, Outlook, and Vista Basic.
Why This Is Dangerous
Backflow from secondary piggyback IV containers into primary IV containers can alter dosing. Inability to prime can prevent proper fluid delivery.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
The recall is high risk for patients who rely on precise IV dosing in clinical settings. No injuries reported yet.
Practical Guidance
How to identify if yours is affected
- Locate Catalog Number 490489 on the device packaging.
- Check Primary UDI-DI 04046955086894 and Unit of Dose UDI-DI 04046955086887.
- Confirm pumps matched include Infusomat Space, Outlook, and Vista Basic Pump.
Where to find product info
Identifiers are on packaging labels and the device itself.
What timeline to expect
Refunds or replacements, if offered, typically take 4-8 weeks after processing.
If the manufacturer is unresponsive
- Escalate to hospital procurement, contact B. Braun Medical, and file with regulatory agencies if needed.
- Seek guidance from your hospital's risk management department.
How to prevent similar issues
- Verify target device model and UDIs before purchase.
- Train staff on identifying recall identifiers.
- Keep recall letters and update asset records.
Documentation advice
Document recall notification, catalog numbers, UDIs, dates, and communications. Photograph labels.
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Product Details
Model numbers: Catalog Number 490489; Primary UDI-DI 04046955086894; Unit of Dose UDI-DI 04046955086887. Sold worldwide, including US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Sold since unknown. Price unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955086887
- Worldwide 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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