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, PETS
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 sets
- Model numbers
- V1443, V1447, V1448, V1484
- 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 sets are used in IV therapy to deliver medications via gravity or pump systems. They are intended for hospital and clinical use.
Why This Is Dangerous
Backflow from piggyback containers into primary IV lines can lead to incorrect dosing or contamination. Inability to prime increases risk of underdelivery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High-risk medical devices with potential to compromise IV therapy accuracy and safety; may require stock withdrawal and replacement.
Practical Guidance
How to identify if yours is affected
- Identify catalog numbers V1443, V1447, V1448, V1484 on the device packaging.
- Verify country of distribution for your facility.
Where to find product info
Refer to FDA recall page Z-0603-2026 and BBMI recall notices.
What timeline to expect
Refunds or replacements via manufacturer coordination; typical timelines span weeks to months.
If the manufacturer is unresponsive
- Escalate to hospital risk management or bulk procurement.
- Document all communications and stock withdrawals.
- Seek assistance from local health authority if the manufacturer is unresponsive.
How to prevent similar issues
- Audit IV sets for ADDitIV components during stocking.
- Coordinate with suppliers to replace affected stock with non-ADDitIV sets if needed.
- Verify UDI codes on incoming stock to prevent renewal of recalled items.
Documentation advice
Keep recall notice, lot numbers, UDIs, purchase records, and communications with supplier for records.
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Product Details
Brand: B Braun Medical. Product: ADDitIV gravity IV administration sets and pump administration sets. Catalog numbers: V1443, V1447, V1448, V1484. UDI-DI: see individual entries. Sold worldwide; US and international distribution to Canada, Germany, Guatemala, Singapore. Recall date: 2025-10-29. Report date: 2025-12-03. Quantity: 43,900 units.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Catalog numbers V1443, V1447, V1448, V1484
- Global distribution including US, Canada, Germany, Guatemala, Singapore
- High hazard level due to backflow and occlusion risk
- No injuries or incidents reported in data
- Recall date 2025-10-29; Report date 2025-12-03
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Safety Guide
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