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
- 490283, 04046964716669, 04046964716652
- 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 through IV lines, connecting bags to patients. They are used with gravity feeds and infusion pumps.
Why This Is Dangerous
Backflow from a secondary (piggyback) container into the primary IV line can lead to unintended dosing. Inability to prime can cause incomplete delivery of medications.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must identify affected stock, halt use, and coordinate refunds or replacements. Stock disruption could impact patient care during admissions or operations.
Practical Guidance
How to identify if yours is affected
- Verify Catalog Number 490283 on the product label.
- Check UDIs: Primary 04046964716669 and Unit of Dose 04046964716652.
- Confirm quantity present in inventory: 65,904 units total.
Where to find product info
Official recall notice and instructions are on the FDA enforcement page for recall Z-0656-2026. Manufacturer communications will also provide details.
What timeline to expect
Refunds or replacements typically processed within 4-8 weeks after confirmation of affected inventory.
If the manufacturer is unresponsive
- Escalate to hospital/health system recall coordinator.
- File a report with your recall liaison.
- If the manufacturer is unresponsive, contact FDA recall helpline for guidance.
How to prevent similar issues
- Implement a recall tracking process for IV sets and other critical devices.
- Verify catalog numbers and UDIs before stocking new supplies.
- Establish supplier recall communication protocols for rapid action.
Documentation advice
Keep the recall letter, inventory lists showing affected Catalog Number 490283, UDIs, and all correspondence with the manufacturer and distributors.
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Product Details
Catalog Number: 490283 Primary UDI-DI: 04046964716669 Unit of Dose UDI-DI: 04046964716652 Distribution: Worldwide US distribution and international distribution to Canada, Germany, Guatemala, and Singapore Quantity: 65,904 units Brand: B. Braun Medical Recall Date: 2025-10-29 Status: ACTIVE Hazard Level: HIGH Product: IV Administration Set used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964716652
- Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
- Recall date 2025-10-29; status ACTIVE; hazard HIGH
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Safety Guide
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