FDA Device recall Z-2409-2023
Legion FMS Pak
- FDA Device
- Class II
- ongoing
- Published 2023-08-23
On 2023-08-23 the FDA classified a Class II recall of Legion FMS Pak by Alcon Research, citing reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2409-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-28 |
| Published | 2023-08-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
Legion FMS Pak
Reason
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Identifiers
| code_info | Catalog No. 8065753164, 8065753165, 8065753166; Product Code 100205822, 100207728, 100207729; UDI-DI: 380657531646, 380…Catalog No. 8065753164, 8065753165, 8065753166; Product Code 100205822, 100207728, 100207729; UDI-DI: 380657531646, 380657531653, 380657531660; Lots 14YTR7, 153UW1, 156YMH, 157R2M. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2409-2023%22
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