Terumo Cardiovascular Systems recalls

Terumo Cardiovascular Systems has 222 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 2 Jul 2025. 6 are still ongoing. The most frequent reason is device malfunction.

Total recalls222since 2012

Last 12 months0reported

Class I00% of total

Ongoing6latest 2 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 1 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 220 99%Class III 2 1%

Why terumo cardiovascular systems is recalled

Product types

By year

202521%
202410%
202331%
202210%
202152%
202084%
201973%
2018125%
201763%
201673%

Ongoing terumo cardiovascular systems recalls

6 active

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Device	CLASS II	CDI OneView System BPM Probe recalled by Terumo Cardiovascular Systems	Terumo Cardiovascular Systems	Labeling Errors	Nationwide
9 Apr 2025Device	CLASS II	Terumo CDI OneView Monitoring System Hematocrit / Oxygen recalled	Terumo Cardiovascular Systems	Device Malfunction	6 states
10 Apr 2024Device	CLASS II	Cardiovascular Procedure Kits that include High Crack Check recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
12 Apr 2023Device	CLASS II	Capiox RX15 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
12 Apr 2023Device	CLASS II	Capiox FX25 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
12 Apr 2023Device	CLASS II	Capiox NX19 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide

All terumo cardiovascular systems recalls, newest first

222 total

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Device	CLASS II	CDI OneView System BPM Probe recalled by Terumo Cardiovascular Systems	Terumo Cardiovascular Systems	Labeling Errors	Nationwide
9 Apr 2025Device	CLASS II	Terumo CDI OneView Monitoring System Hematocrit / Oxygen recalled	Terumo Cardiovascular Systems	Device Malfunction	6 states
10 Apr 2024Device	CLASS II	Cardiovascular Procedure Kits that include High Crack Check recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
12 Apr 2023Device	CLASS II	Capiox RX15 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
12 Apr 2023Device	CLASS II	Capiox FX25 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
12 Apr 2023Device	CLASS II	Capiox NX19 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
27 Apr 2022Device	CLASS II	Cardiovascular Procedure Kit recalled by Terumo Cardiovascular Systems	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
1 Sep 2021Device	CLASS II	Terumo Advanced Perfusion System 1 Electronic Patient Gas System recalled	Terumo Cardiovascular Systems	Device Malfunction	MI
9 Jun 2021Device	CLASS II	The Terumo HX2 Temperature Management System provides recalled	Terumo Cardiovascular Systems	Temperature Abuse	MI
9 Jun 2021Device	CLASS II	The Sarns Temperature Control and Monitor unit (TCM) is a source recalled	Terumo Cardiovascular Systems	Temperature Abuse	MI
9 Jun 2021Device	CLASS II	The Sarns TCM II (system) is a source recalled	Terumo Cardiovascular Systems	Temperature Abuse	MI
14 Apr 2021Device	CLASS II	Consist of a distal connection mechanism recalled	Terumo Cardiovascular Systems	Foreign Material	Nationwide
23 Dec 2020Device	CLASS II	Capiox (West) Advance Oxygenator- with left port Reservoir recalled	Terumo Cardiovascular Systems	Other	Nationwide
23 Sep 2020Device	CLASS II	Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
23 Sep 2020Device	CLASS II	Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3//32 recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
23 Sep 2020Device	CLASS II	Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1//32 recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Terumo Advanced Perfusion System 1 Roller Pump recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Terumo Advanced Perfusion Assembly Pump Guts recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Terumo Advanced Perfusion System 1 Roller Pump recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Terumo Advanced Perfusion Assembly Pump Guts recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
7 Aug 2019Device	CLASS II	Terumo Capiox NX19 Oxygenator (East Orientation) recalled	Terumo Cardiovascular Systems	Other	MI
7 Aug 2019Device	CLASS II	Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) recalled	Terumo Cardiovascular Systems	Other	MI
7 Aug 2019Device	CLASS II	Terumo Capiox NX19 Oxygenator (West Orientation recalled	Terumo Cardiovascular Systems	Other	MI
7 Aug 2019Device	CLASS II	Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) recalled	Terumo Cardiovascular Systems	Other	MI
19 Jun 2019Device	CLASS II	Terumo Advanced Perfusion System 1 Electronic Patient Gas recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
22 May 2019Device	CLASS II	Terumo Advanced Perfusion System 1 Electronic Patient Gas System recalled	Terumo Cardiovascular Systems	Labeling Errors	Nationwide
6 Mar 2019Device	CLASS II	Cardiovascular Procedure Kit (Clr MP4 Coil 2 Spike) recalled	Terumo Cardiovascular Systems	Labeling Errors	TX
31 Oct 2018Device	CLASS II	VirtuoSaph Plus Endoscopic Vessel Harvesting System recalled	Terumo Cardiovascular Systems	Other	Nationwide
24 Oct 2018Device	CLASS II	Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
3 Oct 2018Device	CLASS II	Terumo 100/120V AC, Advanced Perfusion System Platform recalled	Terumo Cardiovascular Systems	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.