Z-1002-2026Class I

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

Name: Z-1002-2026 Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Creator: AVID Medical, Inc.
Published: 2025-11-11
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2025-11-11 / Open, Classified / root cause: manufacturing process

FDA source

AVID Medical, Inc. began a recall of Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 on 2025-11-11. FDA classified it as Class I and gives the reason as "Devices are not suitable for organ transplant". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1002-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-11-11
Posted: 2026-01-02
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Product code: LRO General Surgery Tray
Reason for recall: Devices are not suitable for organ transplant.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 11/11/25 was emailed to consignees instructing them to discontinue use of all recalled kits. Consignees are to discard all unused product. End users are to contact distributors with any questions they may have; Distributors are to forward the recall notification to customers who received distributed product. Adverse events or quality problems can be reported to Owens & Minor at [email protected]. An updated URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 11/17/25 was email to consignees instructing consignees to segregate and quarantine all impacted product remaining in inventory. Consignees are to discontinue use of the 24x30 poly bag included in the affected kits and add the provided warning label to ensure the component is discarded.
Quantity in commerce: 380 units
Distribution: US Nationwide distribution in the states of FL, GA and Puerto Rico.
Product codes and lots: Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1002-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1000-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-02
Z-1001-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-02
Z-1002-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-02

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)