FDA Device recall Z-1200-2023
CustomEyes kits
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of CustomEyes kits by Beaver Visitec International, citing device packaging may contain open seals, compromising product sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1200-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-20 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beaver Visitec International |
| Distribution | AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA, WI |
Product
CustomEyes kits
Reason
Device packaging may contain open seals, compromising product sterility.
Identifiers
| code_info | Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969 |
|---|
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-1200-2023%22
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