FDA DevicesClass I
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Published: January 14, 2026Recall ID: Z-1001-2026Category: devicesCountry: US
Reason for Recall / Hazard
Devices are not suitable for organ transplant.
Product Description & Identification
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Additional Source Details
| Field | Value |
|---|---|
| City | Toano |
| State | VA |
| Event id | 98060 |
| Address 1 | 9000 Westmont Dr |
| Code info | Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709 |
| Postal code | 23168-9351 |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 52 units |
| Reason for recall | Devices are not suitable for organ transplant. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251111 |
| Initial firm notification | |
| Center classification date | 20260102 |
Overview
- Recalling FirmAVID Medical, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionUS Nationwide distribution in the states of FL, GA and Puerto Rico.