Sarns TCM II — Class II medical device recall Z-1418-2018
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2018-04-25, distributed nationwide. Update to cooler-heater cleaning instructions.
| Recall number | Z-1418-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2018-03-16 |
| Classified | 2018-04-17 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2020-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CL, CN, CO, DE, DO, ES, FI, FR, GB, GR, ID, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PH, RU, SA, SE, SG, TH, TR, TW, VN |
| Quantity | 2,393 |
| UPC / GTIN / UDI-DI | 00886799000014 |
| Model numbers | 4415 |
Product
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Reason for recall
Update to cooler-heater cleaning instructions.
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-1418-2018. 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.