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
- 490549, 490565
- 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 medications through gravity or pump-assisted IV systems in clinical settings.
Why This Is Dangerous
Backflow from piggyback to primary IV containers and occlusion can disrupt accurate medication delivery and patient safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may experience workflow disruption and potential patient safety risk if affected sets remain in use.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers 490549 or 490565 on the device label.
- Verify expiration dates match earliest expiration per component or 36 months.
- Confirm device is used with Infusomat Space, Outlook Pump, or Vista Basic Pump.
Where to find product info
Recall notice and FDA enforcement page; manufacturer correspondence will list next steps.
What timeline to expect
Timeline for refunds or replacements is not specified in the recall notice.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- If unresponsive, file a report with FDA MedWatch or local regulatory authorities.
How to prevent similar issues
- Verify backflow prevention design when selecting infusion sets.
- Confirm compatibility with pumps before use.
- Maintain an inventory of affected catalog numbers to prevent reuse.
Documentation advice
Keep the recall notice, serials, UDIs, and all correspondence with the manufacturer.
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Product Details
Catalog Numbers: 490549 and 490565. Primary UDI-DI: 04046955270323 and 04046955275601. Unit of Dose UDI-DI: 04046955270316 and 04046955275595. Expiration: Earliest Expiration of Component or 36 months. Distribution: Worldwide, including US and international distribution to Canada, Germany, Guatemala, and Singapore. Sold through healthcare distributors and hospital systems. Recall date: 2025-10-29. Report date: 2025-12-03. Units recalled: 65,232. Brand: B. Braun Medical Inc.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Catalog numbers 490549 and 490565
- Exp: Earliest Exp of Component or 36 months
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Immediate action required: stop use; follow manufacturer instructions
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Safety Guide
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