Leica M525 F50 Surgical Microscope — Class II medical device recall Z-2053-2012
Terminated recall by Leica Microsystems, Inc., reported 2012-08-01, distributed nationwide. Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be obs
| Recall number | Z-2053-2012 |
|---|---|
| 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 | 2012-06-04 |
| Classified | 2012-07-20 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2012-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | device malfunction |
| Serial numbers | 101011001, 10311002, 10411001, 110112002, 110311001, 111011001, 120312001, 121211001, 130411001, 140212001, 141011001, 141211001, 151211001, 170511001, 191211001, 200312001, 200911001, 20312001, 20412001, 20911001, 210411001, 210911001, 220312001, 241011001, 241011002 and 18 more |
Product
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Reason for recall
Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.
Machine access
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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.