CIRRUS HD-OCT — Class II medical device recall Z-0723-2022
Ongoing recall by Carl Zeiss Meditec, Inc., reported 2022-03-16, distributed nationwide. Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
| Recall number | Z-0723-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec, Inc., Dublin, CA, United States |
| Recall initiated | 2022-01-14 |
| Classified | 2022-03-04 |
| Reported by FDA | 2022-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 1,272 devices |
| Model numbers | 5000 |
Product
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Reason for recall
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
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-0723-2022. 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.