RecallRadar

FDA Device recall Z-1001-2026

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

On 2026-01-14 the FDA classified a Class I recall of Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17 by Avid Medical, citing devices are not suitable for organ transplant.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1001-2026
ClassificationClass I
Statusongoing
Initiated2025-11-11
Published2026-01-14
Last updated2026-09-13 11:58 UTC
CompanyAvid Medical
DistributionUS

Product

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

Reason

Devices are not suitable for organ transplant.

Identifiers

code_infoKit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1001-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.