FDA Device recall Z-2250-2025
GYN LAPAROSCOPY PACK. Medical convenience kit
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of GYN LAPAROSCOPY PACK. Medical convenience kit by Avid Medical, citing CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2250-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-11 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avid Medical |
| Distribution | CA, IL, MD, OH, PA, TX, WA |
Product
GYN LAPAROSCOPY PACK. Medical convenience kit.
Reason
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Identifiers
| code_info | Model No. NAFB055-08, NAMC436-11, VMCC030-06; UDI: 10809160405185, 10809160417621, 10809160415245, 10809160419021; Kit…Model No. NAFB055-08, NAMC436-11, VMCC030-06; UDI: 10809160405185, 10809160417621, 10809160415245, 10809160419021; Kit Lot No. 1595523, 1598524, 1598523, 1628236, 1634348, 1636865, 1645025, 1645227, 1608234, 1608349, 1608466, 1613607, 1613139, 1613608, 1616927, 1622475, 1628656, 1632993, 1596145, 1603597, 1608059, 1619856. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2250-2025%22
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