Recalls / —

—#217520

Product

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

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.

Why it was recalled

Devices are not suitable for organ transplant.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 complaints@owens-minor.com. 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.

Recalling firm

Firm

AVID Medical, Inc.

Address

9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern

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

Timeline

Recall initiated

2025-11-11

Posted by FDA

2026-01-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #217520. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.