The Leica ASP6025 Tissue Processor — Class II medical device recall Z-2804-2015
Terminated recall by Leica Microsystems, Inc., reported 2015-09-30, distributed in AR, AZ, CA, CT, DC, FL, GA, HI…. The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort fi
| Recall number | Z-2804-2015 |
|---|---|
| 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 | 2015-07-27 |
| Classified | 2015-09-22 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2017-01-05 |
| Distributed | AR, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, WV |
| Countries outside the US | AE, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, ES, FR, GB, ID, IE, IL, IN, IT, JO, JP, KR, KW, LT, MX, MY, NO, PE, PH, PL, QA, RO, RS, SA, SG, SI, TH, TR, TW, ZA |
| Serial numbers | 163, 169, 200-729, 731, 733, 735, 737, 739, 741, 743, 745, 747, 749, 751, 753, 755, 757, 759, 761, 763, 765, 767, 769, 771, 773 and 19 more |
Product
The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Reason for recall
The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor 3, thus not completing a 5 litre fill.
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-2804-2015. 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.