Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
FDA Recall Z-1001-2026 · Posted 2026-01-02
Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2025-11-11
Product Quantity52 units
Reason for Recall
Devices are not suitable for organ transplant.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of FL, GA and Puerto Rico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.