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, PREGNANT, ELDERLY
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: 490193, Catalog Number: 490326
- 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 are used to deliver fluids and medications through IV pumps or gravity systems. They connect to IV bags or bottles and to patient IV catheters.
Why This Is Dangerous
Backflow could transfer medication from the piggyback line into the primary line, potentially altering dose delivery. An occlusion may prevent priming and secure flow.
Industry Context
This recall is not clearly part of a broader industry pattern in the provided data.
Real-World Impact
Health systems may need to replace affected sets and review IV administration protocols to prevent backflow and ensure reliable priming.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number on the IV administration set packaging for 490193 or 490326.
- Check expiration date, if within the next 24 months or earlier.
Where to find product info
UDI codes are on product packaging and accompanying documentation.
What timeline to expect
Refunds or replacements typically process within 4-8 weeks after verification.
If the manufacturer is unresponsive
- Escalate to hospital safety officer or risk management.
- File a complaint with the FDA and request manufacturer escalation.
How to prevent similar issues
- When buying infusion components, verify catalog number and UDI-DI against recall notices.
- Prefer vendors listing recall status on product pages.
- Maintain an inventory of medical devices for tracking recall eligibility.
Documentation advice
Document catalog numbers, UDI codes, dates, supplier communications, and any adverse events or near misses.
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Product Details
IV Administration Set products recalled by B Braun Medical Inc. include: Catalog Number 490193 with Primary UDI-DI 04046964303661 and Unit of Dose UDI-DI 04046964303654; Expiration: Earliest expiration of components or 24 months. Catalog Number 490326 with Primary UDI-DI 04046964541063 and Unit of Dose UDI-DI 04046964541056; Expiration: Earliest expiration of components or 24 months. These sets are labeled for use with gravity IV administration and pump administration with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Distributed worldwide, including US, Canada,
Reported Incidents
No specific injury counts are provided in the available data. The recall status is active with a high hazard level.
Key Facts
- Catalog numbers 490193 and 490326
- Worldwide 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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