BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon… — Class II medical device recall Z-1804-2015
Terminated recall by Beaver-Visitec International Inc., reported 2015-06-24, distributed nationwide. Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
| Recall number | Z-1804-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver-Visitec International Inc., Waltham, MA, United States |
| Recall initiated | 2015-05-01 |
| Classified | 2015-06-15 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2021-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 585 kits |
| Reason classes | sterility |
| Lot numbers | 3039720, 3046211, 3047770, 3049473, 3070763, 3082330, 3089827, 3093682, 3095941, 3106407, 3117874 |
| Model numbers | 584649 |
Product
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
Reason for recall
Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
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-1804-2015. 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.