Terumo Cardiovascular Systems Corporation
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.
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66…
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
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…
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal …
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of…
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a…
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) C…
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand …
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand …
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…
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…
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…
Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulatio…
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…
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within th…
Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within…
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in card…
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control…
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting Sy…
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the…
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product…
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitorin…
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperatu…
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 …
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…
Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy …
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
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…
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
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…
Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an …
Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat …
HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuit…
Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchang…
CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuou…
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon d…
Nearby Manufacturers
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Compare Terumo Cardiovascular Systems Corporation with Zimmer Biomet, Inc. →
Data Sources
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.