Leica ASP6025 Tissue Processor Recalled for Incomplete Bottle Filling
Leica Microsystems is recalling ASP6025 Tissue Processors because they may incorrectly detect empty bottles during filling, preventing the completion of a 5-liter fill.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a functional error (incomplete filling) that does not present an immediate risk of serious injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Leica Microsystems, Inc. is recalling the Leica ASP6025 Tissue Processor, an automated system used in pathology and hematology departments to process tissue specimens. The recall involves 163 systems distributed in the United States and 410 systems distributed internationally.
The recall is being conducted because the instrument may incorrectly enter a 'bottle empty' state during the retort filling process. This error occurs after the fill lever passes sensor 2 and before reaching level sensor 3, which prevents the machine from completing a 5-liter fill. The affected serial numbers range from 163 to 811, with specific exclusions noted in the official record.
The affected units were distributed to pathology and hematology departments in various U.S. states and numerous foreign countries. Users of these devices should contact Leica Microsystems for further instructions regarding the recall and potential corrective actions.
The recalled product
- 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.
- Manufacturer
- Leica Microsystems, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: Leica ASP6025 Serial Numbers: 163
- 169
- 200-729
- 731
- 733
- 735
- 737
- 739
- 741
- 743
- 745
- 747
- 749
- 751
- 753
- 755
- 757
- 759
- 761
- 763
Distribution
Related recalls
Same manufacturer · Leica Microsystems, Inc.
See all →- HighSurgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown
FDA (Devices) · 2022-12-21
- HighSurgical microscope power supply may overheat and cause unexpected shutdown
FDA (Devices) · 2022-12-21
- HighLeica Provido surgical microscope models at risk of unexpected power shutdown
FDA (Devices) · 2022-12-21
- HighLeica Surgical Operating Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
- HighLeica M530 Surgical Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07