Terumo HX2 Temperature Management System — Class II medical device recall Z-1416-2018
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2018-04-25, distributed nationwide. Update to cooler-heater cleaning instructions.
| Recall number | Z-1416-2018 |
|---|---|
| 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 this |
| Model numbers | 809810 |
Product
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
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-1416-2018. 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.