FDA Device Recall Z-1001-2026

AVID Medical, Inc. · Toano, VA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

Lot / serial / GTIN: Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709

Quantity: 52 units

Reason for recall

Devices are not suitable for organ transplant.

Recall record

Recall number: Z-1001-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US Nationwide distribution in the states of FL, GA and Puerto Rico.
Recall initiated: 2025-11-11
Classified by FDA Center: 2026-01-02
FDA published: 2026-01-14
Recalling firm: AVID Medical, Inc.
Firm location: Toano, VA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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