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
- 490612, 04046955664610, 04046955664603
- 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 fluids and medications from a reservoir to a patient via gravity or pump-assisted systems. This recall concerns a piggyback configuration used with several BBraun infusion pumps and related components.
Why This Is Dangerous
Backflow from secondary containers into primary IV lines could result in incorrect dosing or contamination. Inability to prime can lead to under-delivery of fluids or medications.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt use, quarantine affected lots, and replace with safe alternatives. The recall could affect patient monitoring and drug administration workflows.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490612 on packaging
- Verify Primary UDI-DI 04046955664610
- Verify Unit of Dose UDI-DI 04046955664603
- If matched, do not use the device and contact the manufacturer for instructions
Where to find product info
FDA enforcement page for Z-0677-2026 and the manufacturer's recall notice
What timeline to expect
4-8 weeks for replacement or refund after processing
If the manufacturer is unresponsive
- File a complaint with the FDA CDRH recall portal
- Notify hospital risk management
- Consider legal consultation if there are injuries or unaddressed issues
How to prevent similar issues
- Ask suppliers for recall status before purchasing IV sets
- Verify UDIs and catalog numbers before clinical use
- Maintain an updated stock management process to isolate recalled lots
Documentation advice
Keep recall notices, packaging, delivery receipts, and correspondence with the manufacturer. Photograph affected serial numbers and UDIs for records.
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Product Details
Catalog Number: 490612; Primary UDI-DI: 04046955664610; Unit of Dose UDI-DI: 04046955664603; Expiration Date: Earliest Expiration of Component or 36 months; Sold Worldwide including US, Canada, Germany, Guatemala, Singapore; Recall Date: 2025-10-29; Quantity: 5,952 units; Brand: B. Braun Medical; Used with: Infusomat Space Large Volume Pump, Outlook Pump, Vista Basic Pump
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955664603
- Expiration: earliest expiration or 36 months
- Hazard: backflow risk and occlusion potential
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Safety Guide
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