Leica Microsystems products labeled as the following: Leica M320… — Class II medical device recall Z-2555-2018
Terminated recall by Leica Microsystems, Inc., reported 2018-08-01, distributed nationwide. Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas s
| Recall number | Z-2555-2018 |
|---|---|
| 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 | 2018-06-04 |
| Classified | 2018-07-26 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2021-03-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BG, BO, BR, CA, CL, CN, DE, DK, EG, ES, FI, FR, GB, HU, IL, IN, IT, JP, KR, KW, MY, PH, PL, PT, SA, SE, SG, SK, SV, TH, TR, TW, ZA |
| Quantity | 8,564 total |
| Serial numbers | 011014001, 011014002, 011014003, 011014004, 021014001, 021014002, 031014001, 031014002, 031014003, 031014004, 040814001, 040814002, 040814003, 040814004, 050814001, 050814002, 050814003, 050814004, 060814001, 060814002, 070814001, 070814002, 070814003, 070814004, 080814001 and 475 more |
Product
Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.
Reason for recall
Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier.
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-2555-2018. 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.