TRAY RING COVER — Class II medical device recall Z-1033-2022
Ongoing recall by Johnson & Johnson Surgical Vision Inc, reported 2022-05-11, distributed nationwide. Potential breach in the sterility barrier for tray ring covers.
| Recall number | Z-1033-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Surgical Vision Inc, Santa Ana, CA, United States |
| Recall initiated | 2022-04-06 |
| Classified | 2022-05-04 |
| Reported by FDA | 2022-05-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, ID, IN, JP, MY, PH, TW |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 05050474520707 |
| Model numbers | OM271000 |
Product
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Reason for recall
Potential breach in the sterility barrier for tray ring covers.
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-1033-2022. 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.