CustomEyes kits — Class II medical device recall Z-1200-2023
Ongoing recall by Beaver Visitec International, Inc., reported 2023-03-08, distributed in AL, CA, CO, DC, FL, GA, IL, LA…. Device packaging may contain open seals, compromising product sterility.
| Recall number | Z-1200-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver Visitec International, Inc., Waltham, MA, United States |
| Recall initiated | 2022-12-20 |
| Classified | 2023-03-01 |
| Reported by FDA | 2023-03-08 |
| Distributed | 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 |
| Countries outside the US | CA, JP, ZA |
| Quantity | 4,640 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 50886158021969, 50886158021990 |
| Lot numbers | 6051841, 6051842, 6052299, 6052300 |
| Model numbers | BVI-58001086, BVI-58001089 |
Product
CustomEyes kits
Reason for recall
Device packaging may contain open seals, compromising product sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1200-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.