CAPIOX RX15 Hollow Fiber Oxygenator — Class II medical device recall Z-1345-2023
Ongoing recall by Terumo Cardiovascular Systems Corporation, reported 2023-04-12, distributed nationwide. Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded t
| Recall number | Z-1345-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2023-03-01 |
| Classified | 2023-04-05 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CR, TH |
| Quantity | 1,412 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00699753450134 |
| Lot numbers | 2M10 |
Product
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Reason for recall
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
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-1345-2023. 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.