Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular… — Class II medical device recall Z-1815-2013
Terminated recall by Leica Microsystems, Inc., reported 2013-08-07, distributed nationwide. The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use
| Recall number | Z-1815-2013 |
|---|---|
| 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 | 2012-11-13 |
| Classified | 2013-07-29 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2017-01-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CH, CL, DE, ES, FR, GB, IE, IT, JP, MX, MY, NL, SG, TH, TR, ZA |
| Quantity | 128 machines |
| Serial numbers | 162, 163, 168, 169, 170, 171, 183, 184, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216 and 103 more |
| Model numbers | 120V/50-60, 230V/50-60, ASP6025 |
Product
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
Reason for recall
The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice.
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-1815-2013. 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.