Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17 recallZ-1001-2026 · AVID Medical, Inc. · initiated Nov 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AVID Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices are not suitable for organ transplant.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1001-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 11, 2025
- Posted by the FDA
- Jan 2, 2026
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 52 units
- Product code
- LRO
- Distribution
- US Nationwide distribution in the states of FL, GA and Puerto Rico.
Product description
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Code information (models, lots, serial numbers)
Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard LLOF1000-17_0012Avid Medical, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98060).
- Z-1000-2026 · Open, ClassifiedHalyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
- Z-1002-2026 · Open, ClassifiedHalyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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