Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
- Company
- Avid Medical, Inc.
- Recall Initiated
- November 11, 2025
- Posted
- January 2, 2026
- Recall Number
- Z-1001-2026
- Quantity
- 52 units
- Firm Location
- Toano, VA
Reason for Recall
Devices are not suitable for organ transplant.
Distribution
US Nationwide distribution in the states of FL, GA and Puerto Rico.
Lot / Code Info
Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709
Root Cause
Nonconforming Material/Component
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.