Quick Facts at a Glance
- Recall Date
- November 11, 2025
- Hazard Level
- HIGH
- Brand
- AVID Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- 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
- AVID Medical
- Product type
- Organ Transplant Device
- Model numbers
- Kit Code: JACK097-08, UDI : 10809160462829, Lot No: 1654185
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 11, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Devices are not suitable for organ transplant.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact AVID Medical, Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The Halyard MINI PLUS KIT SOUTH is a medical device used in organ transplant procedures. Healthcare providers rely on it for safe and effective patient care during transplants.
Why This Is Dangerous
The devices pose a risk in organ transplant situations due to their unsuitability, potentially leading to serious health complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must find alternative solutions quickly to ensure safety during organ transplant procedures.
Practical Guidance
How to identify if yours is affected
- Locate the Kit Code on the packaging: JACK097-08.
- Check for the UDI number: 10809160462829.
- Verify the Lot Number: 1654185.
Where to find product info
Serial numbers and lot numbers are typically found on the product packaging or the device label.
What timeline to expect
Expect a refund or replacement within 4-8 weeks after initiating the recall process.
If the manufacturer is unresponsive
- Document all communications with AVID Medical
- Reach out to the FDA for assistance
- Consider filing a complaint if no response is received.
How to prevent similar issues
- Look for FDA-approved devices for organ transplant procedures in the future.
- Check for recall notifications before purchasing medical devices.
- Ensure that devices have appropriate certifications and labeling.
Documentation advice
Keep records of emails, receipts, and any other correspondence related to the recall.
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Product Details
The recalled product is the Halyard MINI PLUS KIT SOUTH with Kit Code: JACK097-08. The devices were distributed across the U.S., specifically in Florida, Georgia, and Puerto Rico.
Key Facts
- Distributed in FL, GA, and Puerto Rico
- Class I recall indicates high risk
- Immediate cessation of use required
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Safety Guide
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