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
- Anesthesia IV Set
- Model numbers
- Catalog Number: 490452, Primary UDI-DI: 04046964848933, Unit of Dose UDI-DI: 04046964848926
- 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
The Anesthesia IV Set is used with gravity and pump-based IV administration in hospital settings, including compatibility with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
Why This Is Dangerous
A backflow risk could lead to improper dosing or contamination of the primary IV line. An occlusion may prevent proper priming of the line, delaying or stopping medication delivery.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt use of affected sets, switch to alternate IV sets, and coordinate patient care to avoid dosing errors.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 490452 on device label or packaging
- Verify Primary UDI-DI 04046964848933 and Unit of Dose UDI-DI 04046964848926
- Confirm device was used with Infusomat Space Large Volume Pump, Outlook Pump, or Vista Basic Pump
- If affected, stop use and follow manufacturer instructions
Where to find product info
Labels on the device and packaging; recall notice page from FDA/recall URL
What timeline to expect
Not specified in the notice. Monitor the official recall page for updates.
If the manufacturer is unresponsive
- Document all communications with the hospital procurement, device liaison, and the manufacturer
- Escalate to hospital compliance if manufacturers are slow to respond
- Consult regulatory guidance if consumer questions arise
How to prevent similar issues
- Verify device identifiers (Catalog 490452 and UDIs) before clinical use
- Maintain traceability of IV sets used in surgeries or critical care
- Request replacements only through authorized channels
- Monitor for recall updates from FDA and manufacturer communications
Documentation advice
Keep the recall notice, device labels, and all correspondence; photograph labels and store documentation for audit
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Catalog Number: 490452; Primary UDI-DI: 04046964848933; Unit of Dose UDI-DI: 04046964848926; Quantity: 19,392 units; Distribution: Worldwide distribution with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964848926
- Worldwide distribution; US and international distribution to Canada, Germany, Guatemala, Singapore
- Hazard: backflow of medication and inability to prime (occlusion)
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.