Recall Z-1000-2026 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
| Date | Jan 2, 2026 (initiated Nov 11, 2025) |
| Status | Open, Classified |
| Reason | Devices are not suitable for organ transplant. |
| Root cause | Nonconforming Material/Component |
| 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 complaints@owens-minor.com. An updated URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 11/17/25 was email to consignees instructing consignees to segregate and quaran |
| Quantity | 132 units |
| Distribution | US Nationwide distribution in the states of FL, GA and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.