Leica M530 OHX Microscope System Supplied with 100 — Class II medical device recall Z-2659-2018
Terminated recall by Leica Microsystems, Inc., reported 2018-08-15, distributed in AR, AZ, CA, CO, CT, DE, FL, IL…. Recall is due to a design weakness of the power insert module.
| Recall number | Z-2659-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2018-06-25 |
| Classified | 2018-08-07 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2019-02-26 |
| Distributed | AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, KY, LA, MO, NJ, NV, NY, OH, OR, PA, PR, TX, UT |
| Countries outside the US | BR, EC, JP, MX, TW |
| Quantity | 123 devices |
Product
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Reason for recall
Recall is due to a design weakness of the power insert module.
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-2659-2018. 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.