Shimadzu Corp. Analytical & Measuring Instruments Div.: Medical Device Recall in 2024 - (Recall #: Z-0553-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

Product Classification:

Class II

Date Initiated: October 9, 2024
Date Posted: December 4, 2024
Recall Number: Z-0553-2025
Event ID: 95632
Reason for Recall:

There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.

Status: Ongoing
Product Quantity: 179
Code Information:

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, L20995450022, L20995450023, L20995450024, L20995450025, L20995450026, L20995550027, L20995550028, L20995550029, L20995550030, L20995650031, L20995650032, L20995650033, L20995650034, L20995650035, L20995650036, L20995650037, L20995650038, L20995650039, L20995650040, L20995650041, L20995650042, L20995650043, L20995650044, L20995650045, L20995650046, L20995560001, L20995660002, L20995660003, L20995660004, L20995660005, L20995660006, L20995660007, L20995660008, L20995660009, L20995660010, L20995660011, L20995660012, L20995660013, L20995660014, L20995660015, L20995660016, L20995660017, L20995660018, L20995660019, L20995660020, L20995660021, L20995660022, L20995660023, L20995660024, L20995660025, L20995660026, L20995660027, L20995660028, L20995660029, L20995660030, L20995660031, L20995660032, L20995660033, L20995660034, L20995660035, L20995660036, L20995660037, L20995660038, L20995660039, L20995660040, L20995660041, L20995660042, L20995660043, L20995660044, L20995660045, L20995660046, L20995660047, L20995660048, L20995660049, L20995660050, L20995660051, L20995660052, L20995660053, L20995660054, L20995660055, L20995660056, L20995660057, L20995250009, L20995270001, L20995270002, L20995270003, L20995270004, L20995270005, L20995370006, L20995370007, L20995370008, L20995370009, L20995370010, L20995370011, L20995370012, L20995370013, L20995370014, L20995370015, L20995370016, L20995370017, L20995370018, L20995370019, L20995370020, L20995370021, L20995370022, L20995370023, L20995370024, L20995370025, L20995470028, L20995770032. SIL-20ACHT CL/04540217420124/L20985350001, L20985450002, L20985750003, L20985750004. SIL-30AC CL/04540217420155/L21005250001, L21005250002, L21005250003, L21005250004, L21005250005, L21005250006, L21005250007, L21005350008, L21005350009, L21005350010, L21005350011, L21005350012, L21005350013, L21005350014, L21005350015, L21005350016, L21005350017, L21005350018, L21005350019, L21005350020, L21005350021, L21005350022, L21005350023, L21005350024, L21005450025, L21005550026, L21005550027, L21005650028, L21005650029, L21005750030, L21005750031, L21005570001, L21005570002, L21005670003, L21005670004, L21005670005, L21005670006, L21005670007, L21005670008, L21005770009, L21005770010, L21005770011, L21005770012, L21005770013, L21005770014.

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of MS, AR, TX, CA, MA, MI, FL, OK, WI, IN, MN, OH, NJ, NY, IL, KY, NV, HI, SD, ID, MI, UT, WA, MO, VA, GA and the countries of DE, CN, JP, UY.

Voluntary or Mandated:

Voluntary: Firm initiated