Leica ASP6025 Vacuum Tissue Processor Recalled for Incorrect Bottle Dimensions
Leica Microsystems is recalling 128 ASP6025 tissue processors because the manual lists incorrect dimensions for third-party bottles, risking reagent contamination and tissue loss.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the hazard is limited to a labeling error that creates a theoretical risk of reagent contamination and tissue loss, with no reported injuries or illnesses.
Plain-English summary
Leica Microsystems, Inc. is recalling 128 Leica ASP6025 Vacuum Tissue Processors. These devices are used in laboratories for the fixation, dehydration, and paraffin infiltration of histological tissue specimens. The recall covers units distributed nationwide in the United States and internationally to 20 other countries.
The recall is due to an error in the Instruction for Use (Ref F and previous versions), which specifies incorrect dimensions for Ready To Use (RTU) bottles from suppliers other than Leica. If the device experiences a pressure failure while using a bottle with incorrect dimensions, overflow can occur, leading to the contamination of reagents. Additionally, the current instructions fail to emphasize the importance of checking the filling levels of all reagent bottles prior to every process run. Without this information, there is a risk of tissue damage or loss.
Leica Microsystems is distributing the missing information to all customers via a Field Service Notice to address the labeling error and provide necessary operational guidance.
The recalled product
- 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.
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 128
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)
- 1) Model ASP6025 120V/50-60 Hz
- Serial Numbers: 171
- 200
- 202
- 204
- 206
- 208
- 210
- 212
- 214
- 216
- 218
- 220
- 222
- 224
- 226
- 228
- 230
- 232
- 234
Distribution
Distributed nationwide across the United States.
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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateLeica ASP6025 Tissue Processor Recalled for Incomplete Bottle Filling
FDA (Devices) · 2015-09-30
- ModerateLeica ASP6025 Tissue Processor Recalled for Incorrect Voltage Labeling
FDA (Devices) · 2017-07-12
- LowLeica ASP200S/ASP300S Tissue Processor Recall for Wiring Defect
FDA (Devices) · 2015-09-23
- ModerateLeica HistoCore PEGASUS tissue processor recalled for tissue damage
FDA (Devices) · 2024-06-12
- HighTissue Processor Recall: HistoCore PEGASUS May Produce Damaged Specimens
FDA (Devices) · 2024-05-01
- ModerateLeica Microsystems Recalls LPC Fine Mesh Cassettes for Closure Failure
FDA (Devices) · 2013-06-12