Terumo Cardiovascular Systems recalls
Terumo Cardiovascular Systems appears in 223 official U.S. recall notices indexed by RecallRadar, most recently on 2025-07-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- CDI OneView System BPM Probe: Cat
FDA Device · Class II · 2025-07-02 · Terumo Cardiovascular Systems - Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Device · Class II · 2025-04-09 · Terumo Cardiovascular Systems - Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66…
FDA Device · Class II · 2024-04-10 · Terumo Cardiovascular Systems - CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - Cardiovascular Procedure Kit catalog # 76645 & 73806
FDA Device · Class II · 2022-04-27 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
FDA Device · Class II · 2021-09-01 · Terumo Cardiovascular Systems - The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temp…
FDA Device · Class II · 2021-06-09 · Terumo Cardiovascular Systems - The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extra…
FDA Device · Class II · 2021-06-09 · Terumo Cardiovascular Systems - The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for b…
FDA Device · Class II · 2021-06-09 · Terumo Cardiovascular Systems - Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm wit…
FDA Device · Class II · 2021-04-14 · Terumo Cardiovascular Systems - (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (…
FDA Device · Class II · 2020-12-23 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terum…
FDA Device · Class II · 2020-09-23 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sa…
FDA Device · Class II · 2020-09-23 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sa…
FDA Device · Class II · 2020-09-23 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal…
FDA Device · Class II · 2020-02-19 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in th…
FDA Device · Class II · 2020-02-19 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in th…
FDA Device · Class II · 2020-02-19 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the…
FDA Device · Class II · 2020-02-19 · Terumo Cardiovascular Systems - Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
FDA Device · Class II · 2019-08-07 · Terumo Cardiovascular Systems - Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
FDA Device · Class II · 2019-08-07 · Terumo Cardiovascular Systems - Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold onl…
FDA Device · Class II · 2019-08-07 · Terumo Cardiovascular Systems - Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only w…
FDA Device · Class II · 2019-08-07 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588
FDA Device · Class II · 2019-06-19 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides…
FDA Device · Class II · 2019-05-22 · Terumo Cardiovascular Systems - Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
FDA Device · Class II · 2019-03-06 · Terumo Cardiovascular Systems - VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvest…
FDA Device · Class II · 2018-10-31 · Terumo Cardiovascular Systems - Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
FDA Device · Class II · 2018-10-24 · Terumo Cardiovascular Systems - Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures
FDA Device · Class II · 2018-10-03 · Terumo Cardiovascular Systems - Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures
FDA Device · Class II · 2018-10-03 · Terumo Cardiovascular Systems - CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring…
FDA Device · Class II · 2018-08-22 · Terumo Cardiovascular Systems - Monitor with one Blood Parameter Module and one HSat Probe
FDA Device · Class II · 2018-08-22 · Terumo Cardiovascular Systems - Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary b…
FDA Device · Class II · 2018-08-01 · Terumo Cardiovascular Systems - Flowmeter Module (accessory to Terumo Advanced Perfusion System 1)
FDA Device · Class II · 2018-05-02 · Terumo Cardiovascular Systems - Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature
FDA Device · Class II · 2018-04-25 · Terumo Cardiovascular Systems - Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply te…
FDA Device · Class II · 2018-04-25 · Terumo Cardiovascular Systems - Sarns TCM II, Catalog Numbers: 4415
FDA Device · Class II · 2018-04-25 · Terumo Cardiovascular Systems - Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters
FDA Device · Class II · 2018-04-18 · Terumo Cardiovascular Systems - Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130…
FDA Device · Class II · 2017-12-27 · Terumo Cardiovascular Systems - TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
FDA Device · Class II · 2017-12-27 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard…
FDA Device · Class II · 2017-03-22 · Terumo Cardiovascular Systems - Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound en…
FDA Device · Class II · 2017-03-22 · Terumo Cardiovascular Systems - The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas
FDA Device · Class II · 2017-03-01 · Terumo Cardiovascular Systems - Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
FDA Device · Class II · 2017-03-01 · Terumo Cardiovascular Systems - Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
FDA Device · Class II · 2017-02-22 · Terumo Cardiovascular Systems - CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor du…
FDA Device · Class III · 2016-10-12 · Terumo Cardiovascular Systems - Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for…
FDA Device · Class II · 2016-09-07 · Terumo Cardiovascular Systems - Sarns TCM
FDA Device · Class II · 2016-07-27 · Terumo Cardiovascular Systems - Preamendments device-Sarns Dual Cooler-Heater
FDA Device · Class II · 2016-07-27 · Terumo Cardiovascular Systems