Class II — Beaver Visitec International, Inc.
| Recalling firm | Beaver-Visitec International, Inc. |
|---|---|
| Registered facility | Beaver-Visitec International, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Device packaging may contain open seals, compromising product sterility. |
| Product | CustomEyes kits |
| Quantity | 4640 units in total |
| Distribution | US distribution in 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, and WI OUS distribution to Canada, Japan, and South Africa |
| Initiated | 2022-12-20 |
| Classified | 2023-03-01 |
| Recall number | Z-1200-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beaver Visitec International, Inc. (Z-1200-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91488/
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