Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B. Braun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Catalog Number: 490340, Primary UDI-DI: 04046964590481, Unit of Dose UDI-DI: 04046964590474
- Sizes
- 120 IN
- Sold at
- Unknown
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
The IV Administration Set Quad Manifold is used for gravity IV administration and pump-based IV delivery in clinical settings.
Why This Is Dangerous
Backflow from secondary to primary IV containers can lead to incorrect dosing or contamination. Inability to prime can disrupt fluid delivery and patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to substitute IV sets quickly to avoid interrupted therapy. No injuries are reported in the data provided, but the risk to patient safety is material.
Practical Guidance
How to identify if yours is affected
- 1. Locate Catalog Number 490340 on the device label.
- 3. Confirm 120 inch quad manifold configuration.
Where to find product info
Recall notice and FDA enforcement page linked in the recall data: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0689-2026
What timeline to expect
Refund or replacement typically 4-8 weeks after submission of required information.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to FDA recall contacts if the company is unresponsive.
How to prevent similar issues
- Verify device compatibility with pumps before purchasing.
- Check for UDI and catalog numbers during procurement.
- Maintain recall-ready inventory controls and supplier notices.
Documentation advice
Keep the recall notice, photos of the device labeling, purchase records, and correspondence with the manufacturer.
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Product Details
Catalog Number: 490340 Primary UDI-DI: 04046964590481 Unit of Dose UDI-DI: 04046964590474 Description: IV ADMIN SET, QUAD MANIFOLD, 120 IN Sold: Worldwide distribution including US, Canada, Germany, Guatemala, Singapore Quantity: 25,728 units Recall Date: 2025-10-29 Status: Active Brand: B. Braun Medical
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964590474
- Active recall status
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Safety Guide
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