Leica HistoCore SPECTRA CV Coverslipper — Class II medical device recall Z-0019-2019
Terminated recall by Leica Microsystems, Inc., reported 2018-10-10. Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in
| Recall number | Z-0019-2019 |
|---|---|
| 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 | 2018-09-04 |
| Classified | 2018-10-03 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2020-07-10 |
| Quantity | 1 units |
| Serial numbers | 102 |
Product
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
Reason for recall
Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.
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-0019-2019. 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.