Agency classClass IIOur severity:High FDA (Devices)·Z-0553-2025·Announced 2024-12-04

Shimadzu Autosampler Water Intrusion May Cause Electrical Short Circuit

Shimadzu laboratory autosamplers are being recalled due to water intrusion from a dehumidifier that can cause electrical short circuits. Affected units are distributed worldwide, including across the United States.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with electrical hazard from water intrusion causing short circuits and charring of main board and cables. No injuries or illnesses have been reported. Per rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Shimadzu Corp. has recalled three models of laboratory autosamplers: SIL-20ACXR CL, SIL-20ACHT CL, and SIL-30AC CL. These devices contain a Peltier dehumidifier that can leak condensation water from its internal tray, potentially causing electrical short circuits in the main board.

When a short circuit occurs, the main board can become partly charred along with adjacent cables in severe cases. In less severe cases, the Y motor and surrounding die cast components may become rusty. These failures could result in delays to patient sample testing.

The recall affects 179 units distributed worldwide, including in multiple U.S. states (Mississippi, Arkansas, Texas, California, Massachusetts, Michigan, Florida, Oklahoma, Wisconsin, Indiana, Minnesota, Ohio, New Jersey, New York, Illinois, Kentucky, Nevada, Hawaii, South Dakota, Idaho, Utah, Washington, Missouri, Virginia, Georgia) and internationally. Affected serial numbers for each model have been identified.

The recalled product

Product: Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
Manufacturer: Shimadzu Corp. Analytical & Measuring Instruments Div.
Category: Medical Device — Laboratory Equipment
Hazard: water-intrusion
electrical-short-circuit
electrical-fire
Affected units: 179

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)

Model/UDI-DI/Serial Number: SIL-20ACXR CL/04540217420131/L20995250001
L20995250002
L20995250003
L20995250004
L20995250005
L20995250006
L20995250007
L20995250008
L20995350010
L20995350011
L20995350012
L20995350013
L20995350014
L20995350015
L20995450016
L20995450017
L20995450018
L20995450019
L20995450020
L20995450021

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Same manufacturer · Shimadzu Corp. Analytical & Measuring Instruments Div.

See all →

Moderate
Shimadzu Autosampler Devices Subject to Water Damage Affecting Main Board
FDA (Devices) · 2024-12-04

Same hazard · water intrusion