Leica Surgical Operating Microscopes — Class II medical device recall Z-1851-2022
Ongoing recall by Leica Microsystems, Inc., reported 2022-10-05, distributed nationwide. During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside t
| Recall number | Z-1851-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., deerfield, IL, United States |
| Recall initiated | 2022-08-26 |
| Classified | 2022-09-29 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 32 devices |
| Reason classes | software |
| Serial numbers | 100222001, 100222002, 100522001, 10448950, 110322001, 120322001, 120422001, 140522001, 151221002, 160222001, 160921001, 170921001, 180921001, 210821001, 220821001, 250122001, 260821001, 300122001, 300122002, 301021001, 301021002, 301221001, 40122001, 40222002, 50322001 and 8 more |
| Model numbers | 10448950, 10448976 |
Product
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Reason for recall
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
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-1851-2022. 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.