--- title: "Terumo Cardiovascular Systems Corporation Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Terumo Cardiovascular Systems Corporation recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/terumo-cardiovascular-systems-corporation/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Terumo Cardiovascular Systems Corporation recall records **6** reported ongoing 6 records in this archive. Latest source date May 28, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 28, 2025 FDA device enforcement ### [CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit](https://isitonrecall.com/recall/fda-device-z-2018-2025-cdi-oneview-system-bpm-probe-cat-no-cdi753-cdi-oneview-bpm-probe-cat-no-cdi753tk-cdi-oneview-bpm-pro/) Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes ma... Class II Reported ongoing Distribution: US Nationwide distribution in the states of California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, and Washington. The country of New Zealand. [Official source for CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI On...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2018-2025%22) Mar 3, 2025 FDA device enforcement ### [Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754](https://isitonrecall.com/recall/fda-device-z-1492-2025-terumo-cdi-oneview-monitoring-system-hematocrit-oxygen-saturation-probe-catalog-number-ref-cd1754/) During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out ... Class II Reported ongoing Distribution: US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand [Official source for Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1492-2025%22) Feb 20, 2024 FDA device enforcement ### [Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 7447...](https://isitonrecall.com/recall/fda-device-z-1401-2024-cardiovascular-procedure-kits-that-include-high-crack-check-valve-pn-205307a-part-number-6375-16010/) Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention Class II Reported ongoing Distribution: worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand. [Official source for Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1401-2024%22) Mar 1, 2023 FDA device enforcement ### [CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX\*RX15RE30](https://isitonrecall.com/recall/fda-device-z-1345-2023-capiox-rx15-hollow-fiber-oxygenator-catalog-number-3cx-rx15re30/) 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. Class II Reported ongoing Distribution: US Nationwide. Belgium, Canada, Costa Rica, Thailand. [Official source for CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX\*RX15RE30](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1345-2023%22) Mar 1, 2023 FDA device enforcement ### [CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX\*NX19RE](https://isitonrecall.com/recall/fda-device-z-1346-2023-capiox-nx19-hollow-fiber-oxygenator-catalog-number-3cx-nx19re/) 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. Class II Reported ongoing Distribution: US Nationwide. Belgium, Canada, Costa Rica, Thailand. [Official source for CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX\*NX19RE](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1346-2023%22) Mar 1, 2023 FDA device enforcement ### [CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX\*FX25REC, 3CX\*FX25RWC](https://isitonrecall.com/recall/fda-device-z-1347-2023-capiox-fx25-hollow-fiber-oxygenator-catalog-numbers-3cx-fx25rec-3cx-fx25rwc/) 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. Class II Reported ongoing Distribution: US Nationwide. Belgium, Canada, Costa Rica, Thailand. [Official source for CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX\*FX25REC, 3CX\*FX25RWC](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1347-2023%22) ## Reasons in these listed records - Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccur... - During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value. - Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Terumo Cardiovascular Systems Corporation ### Is there a recall on terumo cardiovascular systems corporation right now? This archive contains 6 records, including 6 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Terumo Cardiovascular Systems Corporation](https://isitonrecall.com/check/?q=Terumo%20Cardiovascular%20Systems%20Corporation) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)