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
- 362032, 362033, 362034, 362043, 362050, 362420, 362431, 362432 +19 more
- 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
Infusion sets enable IV medications to be delivered from a bag or bottle into a patient’s vein. They are used with both gravity and pump-assisted IV systems.
Why This Is Dangerous
Backflow from a secondary IV container into the primary line can lead to incorrect medication dosing. An occlusion can prevent proper priming of the line, risking under- or over-infusion.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers and patients could face delays or interruptions in IV therapy if an affected set is in use. The recall could drive replacement costs and require reeducation on IV administration.
Practical Guidance
How to identify if yours is affected
- Review packaging for catalog numbers 362032 through 490101.
- Cross-check the product label with the recall catalog numbers.
- Verify that the infusion set is intended for Infusomat Space, Outlook, or Vista Basic pumps.
Where to find product info
Recall details available on FDA enforcement page and the manufacturer’s notice.
What timeline to expect
Refunds or replacements typically take 4-8 weeks.
If the manufacturer is unresponsive
- Document all communications with the supplier.
- Escalate to FDA consumer safety complaint if encounters are unresolved.
- Consider legal advice for significant harm or ongoing noncompliance.
How to prevent similar issues
- Always verify recall status before replacing IV sets.
- Ask for recall-safe replacements from the supplier.
- Ensure staff are trained on recognizing catalog numbers and UDI identifiers for IV sets.
Documentation advice
Keep the recall notice, purchase receipts, and all correspondence. Photograph affected packaging and catalog numbers for records.
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Product Details
Catalog Numbers: 362032, 362033, 362034, 362043, 362050, 362420, 362431, 362432, 363010, 363019, 363030, 363230, 363419, 363420, 363421, 363422, 363423, 363424, 363430, 363433, 480254, 480255, 480256, 480258, 480263, 490100, 490101. Distribution: Worldwide distribution including US and international markets such as Canada, Germany, Guatemala, and Singapore. Classification: Class II recall. Quantity: 49,330,370 units. Reason: Potential backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Remedy: Stop using the产品.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution with US and international markets
- Hazard: backflow and inability to prime (occlusion)
- No injuries reported to date
- Recall date: 2025-10-29; Notice date: 2025-12-03
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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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