Class III — 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 III |
| Status | Terminated |
| Reason | An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes. |
| Product | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 |
| Quantity | 1 US; 2 OUS |
| Distribution | US Nationwide distribution in the state of NY. |
| Initiated | 2022-06-24 |
| Classified | 2022-07-25 |
| Terminated | 2025-02-07 |
| Recall number | Z-1465-2022 |
| Initiation | Voluntary: Firm initiated |
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 III recall — Zeiss, Carl Inc (Z-1465-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90554/
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