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U.S. Department of Health and Human Services

Class 1 Device Recall Halyard ORGAN RECOVERY OR PACK

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 Class 1 Device Recall Halyard ORGAN RECOVERY OR PACKsee related information
Date Initiated by FirmNovember 11, 2025
Date PostedJanuary 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1001-2026
Recall Event ID 98060
Product Classification General surgery tray - Product Code LRO
ProductHalyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Code Information Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
Manufacturer Reason
for Recall		Devices are not suitable for organ transplant.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn 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.
Quantity in Commerce52 units
DistributionUS Nationwide distribution in the states of FL, GA and Puerto Rico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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