Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

FDA device recall Z-1001-2026 · posted 2026-01-02 · Open, Classified

Recall details

Recalling firm

AVID Medical, Inc.

Reason for recall

Devices are not suitable for organ transplant.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

LRO

Quantity affected

52 units

Distribution

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

Date initiated

2025-11-11

Date posted

2026-01-02

Location

Toano, VA