PlainRecalls

Terumo Cardiovascular Systems Corporation

Compiled from official public sources by the editorial team.

204 recalls on record · Latest: Jul 2, 2025

Terumo Cardiovascular Systems Corporation Recall Insight

Terumo Cardiovascular Systems Corporation appears on 204 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.201% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 2, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 49 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Sep 16, 2015 to Jul 2, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jul 2, 2025

CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit

FDA Devices Moderate Apr 9, 2025

Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

FDA Devices Moderate Apr 10, 2024

Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66…

FDA Devices Moderate Apr 12, 2023

CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

FDA Devices Moderate Apr 12, 2023

CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

FDA Devices Moderate Apr 12, 2023

CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30

FDA Devices Moderate Sep 1, 2021

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

FDA Devices Moderate Jun 9, 2021

The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to…

FDA Devices Moderate Jun 9, 2021

The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal …

FDA Devices Moderate Jun 9, 2021

The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of…

FDA Devices Moderate Apr 14, 2021

Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a…

FDA Devices Moderate Dec 23, 2020

(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) C…

FDA Devices Moderate Sep 23, 2020

Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand …

FDA Devices Moderate Sep 23, 2020

Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand …

FDA Devices Moderate Sep 23, 2020

Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarn…

FDA Devices Moderate Feb 19, 2020

Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorpo…

FDA Devices Moderate Feb 19, 2020

Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracor…

FDA Devices Moderate Feb 19, 2020

Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulatio…

FDA Devices Moderate Feb 19, 2020

Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracor…

FDA Devices Moderate Aug 7, 2019

Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

FDA Devices Moderate Aug 7, 2019

Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within th…

FDA Devices Moderate Aug 7, 2019

Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW

FDA Devices Moderate Aug 7, 2019

Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within…

FDA Devices Moderate Jun 19, 2019

Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in card…

FDA Devices Moderate May 22, 2019

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control…

FDA Devices Moderate Mar 6, 2019

Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

FDA Devices Moderate Oct 31, 2018

VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting Sy…

FDA Devices Moderate Oct 24, 2018

Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188

FDA Devices Moderate Oct 3, 2018

Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764

FDA Devices Moderate Oct 3, 2018

Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763

FDA Devices Moderate Aug 22, 2018

CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the…

FDA Devices Moderate Aug 22, 2018

Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product…

FDA Devices Moderate May 2, 2018

Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.

FDA Devices Moderate Apr 25, 2018

Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitorin…

FDA Devices Moderate Apr 25, 2018

Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .

FDA Devices Moderate Apr 25, 2018

Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperatu…

FDA Devices Moderate Dec 27, 2017

TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J

FDA Devices Moderate Dec 27, 2017

Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 …

FDA Devices Moderate Mar 22, 2017

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 shell…

FDA Devices Moderate Mar 22, 2017

Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy …

FDA Devices Moderate Mar 1, 2017

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

FDA Devices Moderate Mar 1, 2017

The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or m…

FDA Devices Moderate Feb 22, 2017

Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel

FDA Devices Low Oct 12, 2016

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 during ca…

FDA Devices Moderate Jul 27, 2016

Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an …

FDA Devices Moderate Jul 27, 2016

Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat …

FDA Devices Moderate Jul 27, 2016

HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuit…

FDA Devices Moderate Jul 27, 2016

Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchang…

FDA Devices Moderate Apr 6, 2016

CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuou…

FDA Devices Moderate Sep 16, 2015

CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon d…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Terumo Cardiovascular Systems Corporation with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.