FDA Device recall Z-0183-2024
OPMI LUMERA 300, REF 6137
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of OPMI LUMERA 300, REF 6137 by Carl Zeiss Suzhou, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0183-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-18 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carl Zeiss Suzhou |
| Distribution | US |
Product
OPMI LUMERA 300, REF 6137
Reason
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.
Identifiers
| code_info | UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0183-2024%22
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