Leica Microsystems — Class II medical device recall Z-1499-2016
Terminated recall by Leica Microsystems, Inc., reported 2016-04-27, distributed nationwide. An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination c
| Recall number | Z-1499-2016 |
|---|---|
| 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 | 2016-01-11 |
| Classified | 2016-04-15 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2017-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, CA, CH, CL, CN, CO, DE, EG, ES, FR, GB, GR, IN, IT, JP, MA, MX, MY, NO, PE, PL, PT, QA, RO, SA, SE, TR, TW, ZA |
| Quantity | 381 units |
| Reason classes | device malfunction |
Product
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
Reason for recall
An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.
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-1499-2016. 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.