Cell Observer SD — Class II medical device recall Z-2058-2018
Terminated recall by Zeiss, Carl Inc, reported 2018-06-20, distributed nationwide. In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that
| Recall number | Z-2058-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Zeiss, Carl Inc, Thornwood, NY, United States |
| Recall initiated | 2018-05-08 |
| Classified | 2018-07-11 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,070 units |
Product
Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.
Reason for recall
In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
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-2058-2018. 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.