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 Burette Set
- Model numbers
- Catalog Number: 490252, Primary UDI-DI: 04046955545636, Unit of Dose UDI-DI: 04046955545629
- 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
Burette sets are used to deliver precise volumes of IV medication in hospital settings. They are connected to gravity or pump-based IV systems to regulate dosing.
Why This Is Dangerous
Backflow can cause medication to move from secondary containers into primary ones, delivering incorrect dosages. Occlusion can prevent priming, disrupting IV therapy delivery.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt certain IV delivery workflows. Replacement devices may be required to resume therapy without delay.
Practical Guidance
How to identify if yours is affected
- Check labeling on the burette set for Catalog Number 490252.
- Verify Primary UDI-DI 04046955545636 and Unit of Dose UDI-DI 04046955545629.
- Confirm it is used with Infusomat Space, Outlook Pump, or Vista Basic Pump.
Where to find product info
Identifiers are on the device label and packaging. Recall notices explain the affected lot or unit identifiers.
What timeline to expect
Recall notifications by letter are issued. Replacements or remediation guidance will follow from the manufacturer. Typical processing times may vary,
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate to hospital risk management or C-suite leadership if needed.
- File a report with the FDA if appropriate and required by hospital policy.
How to prevent similar issues
- Use only manufacturer-approved burette sets with compatible pumps.
- Check labels and UDIs before procurement.
- Establish a recall-tracking process for infusion-related devices.
Documentation advice
Keep the recall letter, print or save the official recall page, take photos of labels, and log all correspondence with the manufacturer.
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Product Details
Catalog Number: 490252; Primary UDI-DI: 04046955545636; Unit of Dose UDI-DI: 04046955545629; Quantity: 12,320 units; Distribution: Worldwide (US and international to Canada, Germany, Guatemala, and Singapore).
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI: 04046955545629
- Hazard: backflow into primary IV containers and occlusion
- Distribution: Worldwide (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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