Class II — Zeiss, Carl Inc
| Recalling firm | Carl Zeiss Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit. |
| 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. |
| Quantity | 1070 units to US |
| Distribution | USA (nationwide) |
| Initiated | 2018-05-08 |
| Classified | 2018-07-11 |
| Terminated | 2020-04-21 |
| Recall number | Z-2058-2018 |
| Initiation | FDA Mandated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zeiss, Carl Inc (Z-2058-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80115/
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