Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brands
- BB Braun Medical, B Braun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- BB Braun Medical, B Braun Medical
- Product type
- IV Administration Set
- Model numbers
- 490239, UDI-DI:04046964716423, Unit of Dose UDI-DI:04046964716416
- 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
IV administration sets are used to deliver fluids and medications via intravenous tubing. These sets connect to IV bags or bottles and may be used with automated pumps.
Why This Is Dangerous
Backflow can cause unintended dosing or contamination. Occlusion can prevent proper priming, risking under-delivery or over-delivery of medications.
Industry Context
This recall is not part of a broader industry pattern; it highlights specific device-set compatibility and backflow/occlusion risks.
Real-World Impact
High risk for incorrect dosing and potential contamination if backflow occurs. Timely replacement is essential to maintain safe IV administration.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number: 490239 on the IV administration set barrel.
- Check Expiration: Earliest expiration date per component or 24 months from manufacture.
Where to find product info
UDI labels and catalog numbers on the packaging and on the IV set tubing itself.
What timeline to expect
Replacement or refund timeline to be provided by BBraun Medical Inc; expect weeks to months depending on stock and process.
If the manufacturer is unresponsive
- Document all contact attempts.
- Escalate to FDA recall contact if no response after 30 days.
- Consider legal guidance for medical device recalls if timely remedy is not provided.
How to prevent similar issues
- Verify device compatibility with pumps before use.
- Check for recall notices from FDA/BBraun before procurement.
- Maintain records of lot numbers and UDIs for every IV set purchased.
Documentation advice
Keep recall notice, photos of product, purchase receipts, and correspondence with manufacturer.
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Product Details
Catalog Number: 490239. Primary UDI-DI: 04046964716423. Unit of Dose UDI-DI: 04046964716416. Expiration: earliest expiration of component or 24 months. Quantity: 5,100 units. Distribution: Worldwide including US, Canada, Germany, Guatemala, Singapore.
Reported Incidents
No specific injuries or incidents are mentioned in the provided data. The status is active and hazard level HIGH.
Key Facts
- Unit of Dose UDI-DI 04046964716416
- Expiration: earliest expiration or 24 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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