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, PETS
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
- 490407
- 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 enable intravenous therapy by delivering medications and fluids. The specific BBraun set supports gravity and pump-driven administration.
Why This Is Dangerous
Backflow can cause unintended dosing or contamination of the primary IV line. Occlusion can prevent priming, possibly delaying treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High risk for incorrect dosing and delays in therapy; requires immediate supplier guidance and potential replacement.
Practical Guidance
How to identify if yours is affected
- Check catalog number 490407 on the product packaging or accompanying documentation
- Verify UDI-DI 04046964773242 and Unit of Dose UDI-DI 04046964773235
- Confirm expiration date: earliest expiry or within 36 months of manufacture
- Note the date of sale if available
Where to find product info
FDA recall page Z-0687-2026 and BBraun Medical recall communications
What timeline to expect
Remedies and replacements typically take weeks to a few months depending on supply
If the manufacturer is unresponsive
- Document all contact attempts
- File with hospital biomedical engineering for guidance
- Consider notifying the hospital's recall liaison or risk manager
How to prevent similar issues
- Implement strict labeling for infusion sets
- Verify catalog numbers and UDIs before use
- Maintain inventory controls to segregate recalled lots
- Review infection control and administration protocols to prevent backflow incidents
Documentation advice
Keep copies of recall notices, UDI data, purchase records, and correspondence with BBraun Medical
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Product Details
IV Administration Set W/ CARESITE EXT SET, Catalog Number 490407. Global distribution includes US, Canada, Germany, Guatemala, and Singapore. Unit quantity in recall: 10,896.
Reported Incidents
No specific incidents or injuries are described in the provided data.
Key Facts
- Unit of Dose UDI-DI 04046964773235
- Expiration: earliest expiry or 36 months from manufacture
- Recall date: 2025-10-29; Status: ACTIVE
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Safety Guide
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