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
- Catalog Number 490542, Primary UDI-DI 04046955270187, Unit of Dose UDI-DI 04046955270170
- 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 and fluids through intravenous therapy. They connect to bags or containers and interfaces with pumps in clinical settings.
Why This Is Dangerous
Backflow from secondary IV containers into primary lines can alter dosing. An occlusion can prevent priming and delivery of medications, risking under- or overdosing.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
The recall affects hospital and patient safety for a critical treatment pathway. No reported injuries yet, but the risk could affect patient care and require replacement stock at facilities.
Practical Guidance
How to identify if yours is affected
- Verify Catalog Number 490542 on the device label
- Cross-check Primary UDI-DI 04046955270187 and Unit of Dose UDI-DI 04046955270170
- Check expiration date: earliest expiration or 36 months shelf life
- Review recall notice and instructions from B. Braun Medical
Where to find product info
Recall notice and FDA enforcement page linked in the recall press release
What timeline to expect
Refunds or replacements typically processed within 4-8 weeks after verification
If the manufacturer is unresponsive
- Document all correspondences with the manufacturer
- Escalate to hospital risk management or patient safety officer
- File a complaint with FDA if advised by authorities
How to prevent similar issues
- Verify device compatibility with existing infusion pumps before purchase
- Check UDI numbers and catalog numbers during procurement
- Maintain recall checklists for hospital supply chains
Documentation advice
Keep the recall notice, product packaging, photos of labels, and all communications with the manufacturer for records
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Product Details
Catalog Number: 490542. Primary UDI-DI: 04046955270187. Unit of Dose UDI-DI: 04046955270170. Expiration: Earliest Exp of Component or 36 months. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore. Quantity: 7,008 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955270170
- Earliest Exp of Component or 36 months
- Worldwide distribution: US, Canada, Germany, Guatemala, Singapore
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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