The Leica ASP200S/ASP300S Tissue Processor — Class III medical device recall Z-2779-2015
Terminated recall by Leica Microsystems, Inc., reported 2015-09-23, distributed in AZ, CA, CT, DC, DE, FL, GA, HI…. The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which c
| Recall number | Z-2779-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2015-08-05 |
| Classified | 2015-09-17 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-01-05 |
| Distributed | AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, WV |
| Quantity | 901 |
| Serial numbers | 5259, 5260, 5264, 5266, 5267, 5272, 5273, 5289, 5301, 5310, 5348, 5349, 5356, 5366, 5381, 5385, 5386, 5387, 5388, 5398, 5401, 5403, 5407, 5416, 5426 and 54 more |
Product
The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Reason for recall
The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.
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-2779-2015. 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.