Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B. Braun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- B. Braun Medical
- Product type
- IV administration set
- Model numbers
- Catalog Number: 352062, Primary UDI-DI: 04046964181160, Unit of Use UDI-DI: 04046964181153.
- Sold at
- Unknown
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
ADDitIV gravity IV sets are used to deliver medications via gravity-fed IV therapy. They connect piggyback containers to primary IV lines in clinical care. Users rely on proper priming to ensure accurate dosing.
Why This Is Dangerous
Backflow can cause medications to mix improperly between containers, potentially delivering an incorrect dose. An occlusion can prevent proper flow of IV fluids, delaying treatment.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare settings may need to switch to alternative IV sets. Hospitals and clinics should review inventory and affected lots to prevent medication errors.
Practical Guidance
How to identify if yours is affected
- Check Catalog Number 352062 on your ADDitIV gravity IV sets.
- Verify UDIs: Primary 04046964181160 and Unit of Use 04046964181153.
- Review distribution records for facilities using Infusomat Space, Outlook Pump, or Vista Basic Pump with ADDitIV sets.
Where to find product info
Manufacturer recall letters and the FDA enforcement report provide identification details.
What timeline to expect
Recall actions typically run 4-8 weeks for replacement or corrective actions. Hospital procurement may coordinate direct replacements.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital risk management or facility safety officer if responses are slow.
How to prevent similar issues
- Use only non-vent, backflow-prevention IV sets when applicable.
- Implement double-check procedures for IV line configurations.
- Verify priming technique before IV administration.
Documentation advice
Keep a copy of recall communications, models, lot numbers, and any replacement orders. Maintain logs of any adverse events.
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Product Details
Catalog Number: 352062 Primary UDI-DI: 04046964181160 Unit of Use UDI-DI: 04046964181153 Quantity: 12,700 units Distribution: Worldwide distribution, including the US and international distribution to Canada, Germany, Guatemala and Singapore Sold since: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Use UDI-DI 04046964181153
- Worldwide distribution (US, Canada, Germany, Guatemala, Singapore)
- High-hazard recall (backflow and occlusion)
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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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