CLASS I ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report
Halyard Mini Plus Kit South, Kit recalled by AVID Medical
Avid Medical is recalling Halyard Mini Plus Kit South, Kit, distributed nationwide in the US. The recall was initiated on 11 Nov 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1002-2026
- FDA event ID
- 98060
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Nov 2025
- FDA classified
- 2 Jan 2026
- Reported
- 14 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Nov 2025 | Recall initiated by company | |
| 2 Jan 2026 | Classified by FDA | +52 days |
| 14 Jan 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices are not suitable for organ transplant.
Product as listed by the FDA
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Where it was distributed
US Nationwide distribution in the states of FL, GA and Puerto Rico.
Questions about this recall
Why was it recalled?
Devices are not suitable for organ transplant.
Which lots are affected?
Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
Where was it sold?
US Nationwide distribution in the states of FL, GA and Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98060This product is part of a recall event; the main page for the event is Halyard Organ Recovery OR Pack, Kit recalled by AVID Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Halyard Organ Recovery OR Pack, Kit recalled by AVID Medical | Avid Medical | Other | Nationwide | |
| CLASS I | Halyard Organ Recovery OR Pack, Kit recalled by AVID Medical | Avid Medical | Other | Nationwide |
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