Terumo Capiox NX19 Oxygenator — Class II medical device recall Z-2103-2019
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2019-08-07. Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
| Recall number | Z-2103-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2019-06-14 |
| Classified | 2019-07-30 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2020-06-11 |
| Countries outside the US | BE, JP |
| Quantity | 78 units |
| Lot numbers | XA28, XC12, XC25, XD05, XD27 |
Product
Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Reason for recall
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
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-2103-2019. 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.