Class I — UrgentReported 2026-01-14

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

Reason for Recall

Devices are not suitable for organ transplant.

Recall Number

Z-1001-2026

Classification

Class I

Status

Ongoing

Category

device

Initiated

2025-11-11

Reported

2026-01-14

Distribution

US Nationwide distribution in the states of FL, GA and Puerto Rico.

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.