OPMI LUMERA 300 — Class II medical device recall Z-0183-2024
Ongoing recall by Carl Zeiss Suzhou Co., Ltd., reported 2023-11-01, distributed nationwide. Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause t
| Recall number | Z-0183-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Suzhou Co., Ltd., Suzhou, N/A, China |
| Recall initiated | 2023-08-18 |
| Classified | 2023-10-26 |
| Reported by FDA | 2023-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 8 |
| UPC / GTIN / UDI-DI | 06909262061375 |
| Serial numbers | 06909262061375/6137104455, 6137104233, 6137104480, 6137104613, 6137104620, 6137104623, 6137104627, 6137104678 |
| Model numbers | 6137 |
Product
OPMI LUMERA 300, REF 6137
Reason for recall
Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.
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-0183-2024. 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.