Autosampler — Class II medical device recall Z-0554-2025
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 occurring in the gap between ther
| Recall number | Z-0554-2025 |
|---|---|
| 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 | 48 |
| UPC / GTIN / UDI-DI | 04540217420575, 04540217420582 |
| Serial numbers | CL/04540217420575/L2C305850001, CL/04540217420582/L2C316051002, L2C305950002, L2C306051001, L2C306051002, L2C306051003, L2C306051004, L2C306051005, L2C306051006, L2C306051007, L2C306051008, L2C306051009, L2C306051010, L2C306051011, L2C306051012, L2C306051013, L2C306051014, L2C306051015, L2C306151017, L2C306151018, L2C306151022, L2C306151023, L2C306151024, L2C306151025, L2C306151026 and 25 more |
| Model numbers | SIL-40C, SIL-40CXR |
Product
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Reason for recall
There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of 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-0554-2025. 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.