FDA Medical devices recall ·
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1002-2026
- Date
- (initiated November 11, 2025)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 380 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Why was it recalled?
Devices are not suitable for organ transplant.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
Distribution
US Nationwide distribution in the states of FL, GA and Puerto Rico.
States: Florida Georgia Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1002-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.