Leica MICROSYSTEMS Provido — Class II medical device recall Z-0476-2023
Ongoing recall by Leica Microsystems, Inc., reported 2022-12-21, distributed nationwide. There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal compo
| Recall number | Z-0476-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., deerfield, IL, United States |
| Recall initiated | 2022-11-21 |
| Classified | 2022-12-09 |
| Reported by FDA | 2022-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 38 units |
| Reason classes | device malfunction |
| Serial numbers | 100222001, 100222002, 100522001, 110322001, 120322001, 120422001, 120623001, 130922001, 140522001, 150623001, 151221002, 160222001, 170622001, 171022001, 180622001, 200623001, 250122001, 280622001, 300122001, 300122002, 301221001, 30922001, 40122001, 40222002, 50322001 and 13 more |
| Model numbers | 10448950, 10448976 |
Product
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Reason for recall
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
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-0476-2023. 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.