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
- 490519, 04046955185238, 04046955186549
- 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 in clinical settings to deliver fluids and medications through IV lines. They can be connected to secondary piggyback containers or primary IV lines.
Why This Is Dangerous
Backflow can contaminate or alter medication delivery. An occlusion can prevent accurate priming, affecting dose delivery and flow.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt use of affected sets, which could disrupt patient care and require reallocation of supplies.
Practical Guidance
How to identify if yours is affected
- Identify Catalog Number 490519 on the packaging or accompanying documentation.
- Match UDIs 04046955185238 (Primary) and 04046955186549 (Unit of Dose) to product in inventory.
- Check distribution notes for US, Canada, Germany, Guatemala, and Singapore.
Where to find product info
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0672-2026
What timeline to expect
Not specified in recall notice. Follow manufacturer instructions for replacement or remediation.
If the manufacturer is unresponsive
- Escalate to hospital risk management or procurement.
- File a report with the FDA recall system if the manufacturer is unresponsive.
How to prevent similar issues
- Implement a process to verify catalog numbers and UDIs before use or stocking.
- Train staff on recognizing recall notices and executing stop-use directives.
- Maintain an up-to-date inventory of IV administration sets and segregate recalled items.
Documentation advice
Keep a copy of the recall notice, record all communications with the manufacturer, and preserve affected product packaging for audit.
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Product Details
Model numbers and identifiers: Catalog Number 490519; Primary UDI-DI 04046955185238; Unit of Dose UDI-DI 04046955186549. Expiration: earliest expiration of component or 36 months. Sold worldwide, including US, Canada, Germany, Guatemala, and Singapore. Quantity: 1,080 units. Distribution: Worldwide distribution.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955186549
- Distributed worldwide (US, Canada, Germany, Guatemala, Singapore)
- Hazard: backflow and occlusion
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Safety Guide
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