FDA Recall Open, Classified

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

Recall: Z-1002-2026 · Initiated November 11, 2025

Recall

Recall Number
Z-1002-2026
Event Number
98060
Firm
AVID Medical, Inc.
FEI Number
1047429
Product Code
LRO
Status
Open, Classified
Root Cause
Nonconforming Material/Component
Initiated
November 11, 2025
Posted
January 2, 2026
Address
9000 Westmont Dr, Toano, VA, 23168-9351

Description

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

Reason

Devices are not suitable for organ transplant.

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.

Distribution

US Nationwide distribution in the states of FL, GA and Puerto Rico.

Quantity

380 units