Leica Microsystems M220 F12 Microscope Systems — Class II medical device recall Z-0412-2022
Terminated recall by Leica Microsystems, Inc., reported 2021-12-29, distributed nationwide. In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope syst
| Recall number | Z-0412-2022 |
|---|---|
| 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 | 2021-11-03 |
| Classified | 2021-12-22 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, DE, DO, DZ, EC, EG, ES, FR, GB, GR, HK, ID, IE, IN, IQ, IT, JP, KR, KW, LB, LV, MA, MX, MY, NG, NI, NL, NO, NZ, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SK, TH, TR, TW, UA, UY, VN, ZA |
| Quantity | 2,800 |
| UPC / GTIN / UDI-DI | 07630003552188 |
| Serial numbers | 100212001, 100212002, 100212003, 100212004, 100212005, 100614001, 100810004, 101212001, 101212002, 10712002, 110315001, 110614001, 111113001, 111212001, 120615003, 130913001, 130913002, 140510004, 140510005, 150211001, 151209004, 161013001, 170212001, 171116001, 171116002 and 52 more |
| Model numbers | 10448367 |
Product
Leica Microsystems M220 F12 Microscope Systems
Reason for recall
In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
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-0412-2022. 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.