Autosampler — Class II medical device recall Z-0553-2025
Ongoing recall by Shimadzu Corp. Analytical & Measuring Instruments Div., reported 2024-12-04, distributed nationwide. There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidi
| Recall number | Z-0553-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Corp. Analytical & Measuring Instruments Div., Kyoto, Japan |
| Recall initiated | 2024-10-09 |
| Classified | 2024-11-26 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 179 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 04540217420124, 04540217420131, 04540217420155 |
| Serial numbers | CL/04540217420124/L20985350001, CL/04540217420131/L20995250001, CL/04540217420155/L21005250001, L20985450002, L20985750003, L20985750004, L20995250002, L20995250003, L20995250004, L20995250005, L20995250006, L20995250007, L20995250008, L20995250009, L20995270001, L20995270002, L20995270003, L20995270004, L20995270005, L20995350010, L20995350011, L20995350012, L20995350013, L20995350014, L20995350015 and 157 more |
| Model numbers | SIL-20ACHTCL, SIL-20ACXRCL, SIL-30ACCL |
Product
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
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.
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-0553-2025. 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.