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: 490653, Primary UDI-DI: 04046955836338, Unit of Dose UDI-DI: 04046955836345
- 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 intravenous medications through gravity or pump systems. They connect to IV bags or bags and have Y-sites for secondary administration. They are used in hospital, clinic, and sometimes homecare settings.
Why This Is Dangerous
Backflow from secondary to primary IV containers can result in incorrect dosing or contamination. Inability to prime may delay therapy and require additional clinical intervention.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The recall could disrupt IV therapy delivery and require immediate replacement with safe equipment, potentially increasing clinical workload and costs.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490653 on the device label
- Verify UDIs: Primary 04046955836338 and Unit of Dose 04046955836345
- Look for labels indicating IV ADMIN 15D, 2 B/C VLV, CARESITE LADS
Where to find product info
Recall details and guidance are available via the FDA enforcement page and the manufacturer’s website.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after confirmation and return of affected parts.
If the manufacturer is unresponsive
- Escalate with the hospital’s supplier or biomedical engineering team
- File a consumer safety complaint with the CPSC if needed
- Consider contacting FDA for guidance if the manufacturer is unresponsive
How to prevent similar issues
- Verify all IV sets against catalog numbers and UDIs before use
- Purchase only from authorized suppliers
- Maintain an inventory control process to avoid reusing single-use IV sets
- Regularly review recall databases for updates on field actions
Documentation advice
Keep the recall letter, take photos of product labels and UDIs, document dates of purchase and usage, save all correspondence with the manufacturer
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Product Details
Catalog Number: 490653; Primary UDI-DI: 04046955836338; Unit of Dose UDI-DI: 04046955836345; Sold worldwide including US, Canada, Germany, Guatemala, Singapore; Quantity: 48 units; Model variants labeled with catalog number 490653; Labeled as IV ADMIN 15D, 2 B/C VLV, CARESITE LADS
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 48 units
- Unit of Dose UDI-DI: 04046955836345
- Distributed worldwide: US, Canada, Germany, Guatemala, Singapore
- Hazard: backflow risk and occlusion of prime
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Safety Guide
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