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
- 490511, 04046955135875, 04046955135868
- 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 via gravity or pump-based systems in hospital and clinical settings.
Why This Is Dangerous
Backflow into primary IV containers and occlusion could lead to incorrect dosing or interrupted therapy, posing patient safety risks.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare facilities may need to halt use of affected sets and initiate replacements or refunds, with potential operational disruption.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490511 on the product label.
- Confirm Primary UDI-DI 04046955135875 and Unit of Dose UDI-DI 04046955135868.
- Verify the description reads IV ADMIN SET W/ 15 DROPS/ML.
Where to find product info
Labeling and packaging contain UDI codes; recall page provides guidance.
What timeline to expect
4-6 weeks for refunds or replacements in typical recalls.
If the manufacturer is unresponsive
- Document all communications with the supplier.
- Escalate to hospital purchasing or compliance departments if needed.
How to prevent similar issues
- Always verify UDI codes before installation.
- Maintain inventory controls to isolate affected lots quickly.
- Consult manufacturer before replacing or reusing IV sets.
Documentation advice
Retain recall notice, packing labels, and correspondence for records.
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Product Details
Catalog Number: 490511 Primary UDI-DI: 04046955135875 Unit of Dose UDI-DI: 04046955135868 Description: IV ADMIN SET W/ 15 DROPS/ML Sold worldwide including US, Canada, Germany, Guatemala, Singapore Quantity: 12,168 units Expiration: Earliest Expiration of Component or 36 months Additional info: Distributed worldwide; labeled with catalog and UDI numbers.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046955135868
- IV SET W/ 15 DROPS/ML
- Global distribution including 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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