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
- 490522, 490568
- Sizes
- 116 in, 9 in
- 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 connect IV fluids to a patient. They can be used with gravity or pump systems such as BBraun Infusomat Space, Outlook Pump, and Vista Basic Pump.
Why This Is Dangerous
The defect allows backflow of medication from secondary containers into the primary line and may prevent proper priming, risking dose errors or contamination.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
41,016 units recalled; high-risk device. Immediate action required to prevent potential medication backflow or occlusion.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers 490522 and 490568.
- Look for Expiration dates stating earliest expiry within 36 months.
Where to find product info
Label on packaging and accompanying recall letter.
What timeline to expect
Remedy steps and replacement information will be provided by the manufacturer; processing times vary by facility.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate to hospital procurement or regulatory authorities if no response within a reasonable period.
How to prevent similar issues
- Verify infusion sets against recall lists before use.
- Choose IV sets with clear UDIs and expiration dates.
- Report any concerns to the supplier and monitor recall notices.
Documentation advice
Retain recall letter, take photographs of packaging and labels, save UDIs and catalog numbers, log communications with the manufacturer.
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Product Details
Catalog numbers: 490522 and 490568. Primary UDI-DI: 04046955203123; Unit of Dose UDI-DI: 04046955203116; Expiration: earliest expiration of component or 36 months. Catalog number: 490568; Primary UDI-DI: 04046955275663; Unit of Dose UDI-DI: 04046955275656; Expiration: earliest expiration of component or 36 months. Sold worldwide, including US, Canada, Germany, Guatemala, and Singapore.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Catalog numbers 490522 and 490568
- Global distribution to 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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