ZEISS Axio Observer 5 microscope — Class III medical device recall Z-1465-2022
Terminated recall by Zeiss, Carl Inc, reported 2022-08-03, distributed nationwide. An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
| Recall number | Z-1465-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zeiss, Carl Inc, Thornwood, NY, United States |
| Recall initiated | 2022-06-24 |
| Classified | 2022-07-25 |
| Reported by FDA | 2022-08-03 |
| Terminated | 2025-02-07 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04064897000075 |
| Serial numbers | 3859001079 |
Product
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Reason for recall
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
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-1465-2022. 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.