# FDA recall Z-1200-2023

> **Beaver Visitec International, Inc.** · Class II · device recall initiated 2022-12-20.

## Product

CustomEyes kits

## Reason for recall

Device packaging may contain open seals, compromising product sterility.

## 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

## Key facts

- **Recall number:** Z-1200-2023
- **Recalling firm:** Beaver Visitec International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-20
- **Report date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1200-2023

## Citation

> AI Analytics. FDA recall Z-1200-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1200-2023. Source: US FDA. Licensed CC0.

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