Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- BBMI Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- BBMI Medical
- Product type
- IV administration set
- Model numbers
- 352636, 352639, 352640, 352643, 477003, 477006, 477008, 477012 +42 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
IV administration sets connect IV bags to patients. These are used in gravity and pump-assisted administration.
Why This Is Dangerous
Backflow can cause medication contamination or incorrect dosing. Occlusion can prevent proper flow of IV fluids.
Industry Context
This recall is not explicitly described as part of a broader industry pattern in the data.
Real-World Impact
Large-scale recall affecting medical facilities. Potential disruption to IV therapy and device replacement timelines.
Practical Guidance
How to identify if yours is affected
- Review catalog numbers listed in recall
- Cross-check with supplier inventory and serials/UDI where available
- Consult facility risk management for remediation plan
Where to find product info
Recall notice and FDA page with recall number Z-0670-2026
What timeline to expect
Remediation timelines vary; replacement or refunds advised by BBMI
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File complaint with FDA if supplier unresponsive
- Consult legal counsel for prolonged non-compliance
How to prevent similar issues
- Verify device compatibility before use
- Maintain updated inventory of safe IV sets
- Establish recall protocol with suppliers
- Validate UDI numbers for tracing and recall response
Documentation advice
Document catalog numbers, quantities on hand, lot numbers, and correspondence with BBMI
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Product Details
Brand: BBMI Medical. Product: IV Administration Sets. Tools: Used with Infusomat Space Large Volume Pump, Outlook Pump, Vista Basic Pump. Catalog numbers span 352636 to 490589 with 49 distinct items. Distribution: Worldwide; US and international (Canada, Germany, Guatemala, Singapore). Recall date: 2025-10-29. Report date: 2025-12-03.
Reported Incidents
No specific injuries or incidents are detailed in the provided data.
Key Facts
- Catalog numbers range 352636 through 490689 approximately
- Primary issues include backflow risk and occlusion risk
- Global distribution including US, Canada, Germany, Guatemala, Singapore
- Recall effective 2025-10-29; report 2025-12-03
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Safety Guide
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