ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL — Class II medical device recall Z-2163-2025
Ongoing recall by Johnson & Johnson Vision Care, Inc., reported 2025-07-30, distributed nationwide. Due to defects (bubbles/voids) identified during standard finished goods testing
| Recall number | Z-2163-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Vision Care, Inc., Jacksonville, FL, United States |
| Recall initiated | 2025-06-12 |
| Classified | 2025-07-23 |
| Reported by FDA | 2025-07-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BM, CA, CH, DE, DK, ES, FR, GB, IT, KR, NL, PL, SE, SG |
| Quantity | 114,165 lenses |
| UPC / GTIN / UDI-DI | 00888290918355, 00888290918416, 00888290918973, 00888290919000, 00888290919031, 00888290919109, 00888290919116, 00888290919598, 00888290919642, 00888290919666, 00888290919703, 00888290919710, 00888290919727, 00888290919734, 00888290920112, 00888290920389, 00888290920464, 00888290920730, 00888290920754, 00888290920921, 00888290920938, 00888290920983, 00888290921027, 00888290921041, 00888290921072 and 10 more |
Product
ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
Reason for recall
Due to defects (bubbles/voids) identified during standard finished goods testing
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-2163-2025. 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.