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Terumo Cardiovascular Systems Corporat
Terumo Cardiovascular Systems Corporation: 204 FDA recall reports
Every medical device recall the FDA has published for Terumo Cardiovascular Systems Corporation. The fault, and how the agency graded it.
204Reports
0Class I
6Ongoing
2025-07-02Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM
Z-2018-2025 · Class II · reported 2025-07-02 · Ongoing
- Why it was recalled
- 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 inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
- Product
- CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
- Where it went
- 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.
- How much
- 28 US; 7 OUS
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Z-1492-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- 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.
- Product
- Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
- Where it went
- US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
- How much
- 37 units
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974
Z-1401-2024 · Class II · reported 2024-04-10 · Ongoing
- Why it was recalled
- 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
- Product
- 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 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534 75607 75765 75797 75833 75903 75956 75973 76131 76178 76278 76306 76398 76427 76498 76519 76536 76565 76575 76628 76630 76635 76644 76687 76725 76775 76789 76832 76839 76878 76900 76999 77010 77014 77015 77105 77227 77299 77304 77305 77412 77450 77496 77516 77629 77722 77742 77757 77791 77794 77796 78018 78027 165720 205307A 65046-03 65080-06 65167-06 65934-01 65940-01 66041-01 66154-01 66503-02 70148-02 70178-06 70188-05 70638-07 70664-02 70665-01 70734-03 71064-01 71432-02 71433-01 71546-02 71733-02 71754-04 71801-02 71820-01 71928-06 71934-04 72073-02 72149-01 72226-06 72326-07 73008-02 73346-01 73567-01 73568-01 73776-04 73783-02 73882-03 74172-03 74685-01 74734-01 74833-01 74879-07 74921-02 74965-03 74965-04 74972-01 75030-01 75050-02 75068-01 75159-01 75293-01 75409-01 75409-02 75410-01 75410-02...
- Where it went
- worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand.
- How much
- 20,533 units
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Z-1346-2023 · Class II · reported 2023-04-12 · Ongoing
- Why it was recalled
- 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.
- Product
- CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
- Where it went
- US Nationwide. Belgium, Canada, Costa Rica, Thailand.
- How much
- 84 units
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Z-1347-2023 · Class II · reported 2023-04-12 · Ongoing
- Why it was recalled
- 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.
- Product
- CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
- Where it went
- US Nationwide. Belgium, Canada, Costa Rica, Thailand.
- How much
- 4940 units
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Z-1345-2023 · Class II · reported 2023-04-12 · Ongoing
- Why it was recalled
- 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.
- Product
- CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
- Where it went
- US Nationwide. Belgium, Canada, Costa Rica, Thailand.
- How much
- 1412 units
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Z-2350-2021 · Class II · reported 2021-09-01 · Terminated
- Why it was recalled
- intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs
- Product
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
- Where it went
- International distribution in the country of Panama.
- How much
- 1 unit OUS
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an ext
Z-1791-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
- Product
- 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 externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940) TCM (P/N 15747) Catalog Number: 4415, 164925, 164930, 164935, 15747
- Where it went
- Domestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), Vietnam
- How much
- 995 devices
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood hea
Z-1790-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
- Product
- The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940
- Where it went
- Domestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), Vietnam
- How much
- 1176 devices
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits th
Z-1789-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
- Product
- The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to circulate water at a rate of up to 6.5 gal./min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Device Name / Model Number: HX2 Temperature Management System (P/N 809810) Catalog Number: 809810
- Where it went
- Domestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), Vietnam
- How much
- 75 devices
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Conn
Z-1367-2021 · Class II · reported 2021-04-14 · Terminated
- Why it was recalled
- There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
- Product
- Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
- Where it went
- US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
- How much
- 12
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Steril
Z-0565-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
- Product
- (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.
- Where it went
- US Nationwide Foreign: Belgium, India
- How much
- 5,079 Total: 523 US and 4,556 OUS
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intend
Z-2961-2020 · Class II · reported 2020-09-23 · Terminated
- Why it was recalled
- Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
- Product
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
- Where it went
- Worldwide distribution - US Nationwide distribution.
- How much
- 2
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intend
Z-2959-2020 · Class II · reported 2020-09-23 · Terminated
- Why it was recalled
- Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
- Product
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
- Where it went
- Worldwide distribution - US Nationwide distribution.
- How much
- 100
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage
Z-2960-2020 · Class II · reported 2020-09-23 · Terminated
- Why it was recalled
- Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
- Product
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
- Where it went
- Worldwide distribution - US Nationwide distribution.
- How much
- 3
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for
Z-1111-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
- Product
- Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.
- How much
- 11
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated fo
Z-1108-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
- Product
- 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 extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.
- How much
- 33
Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6
Z-1110-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
- Product
- Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.
- How much
- 16
Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated fo
Z-1109-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
- Product
- 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 extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan.
- How much
- 106
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Z-2101-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was recalled
- Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
- Product
- Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
- Where it went
- MI Foreign: Japan, Belgium
- How much
- 16 units
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into conveni
Z-2104-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was recalled
- Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
- Product
- Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
- Where it went
- MI Foreign: Japan, Belgium
- How much
- 123 units
Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
Z-2102-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was recalled
- Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
- Product
- Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
- Where it went
- MI Foreign: Japan, Belgium
- How much
- 52units
Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into conv
Z-2103-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was recalled
- Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
- Product
- Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
- Where it went
- MI Foreign: Japan, Belgium
- How much
- 78 units
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 80
Z-1769-2019 · Class II · reported 2019-06-19 · Terminated
- Why it was recalled
- An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
- Product
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
- Where it went
- Distribution US nationwide, including CA, CT, IL, IN, KY, MI, MN, MO, MT, NM, NY, OH, and WI. Foreign distribution to Canada, Mexico, and South Korea.
- How much
- 72
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The
Z-1337-2019 · Class II · reported 2019-05-22 · Terminated
- Why it was recalled
- The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
- Product
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
- Where it went
- Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.
- How much
- 1258
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Z-0966-2019 · Class II · reported 2019-03-06 · Terminated
- Why it was recalled
- Presence of natural rubber latex is not declared in the label
- Product
- Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
- Where it went
- TX
- How much
- 12 packs
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSap
Z-0227-2019 · Class II · reported 2018-10-31 · Terminated
- Why it was recalled
- The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed from the list of compatible generators within the IFU.
- Product
- VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surge1y for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requit¿ing blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting vc
- Where it went
- Worldwide - US Nationwide in the states of FL, IL, NY, OH, TX. The products were distributed to the following foreign country: Singapore.
- How much
- 135
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Z-0176-2019 · Class II · reported 2018-10-24 · Terminated
- Why it was recalled
- The service manual was not updated at the time of the release of software version 1.30.
- Product
- Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
- Where it went
- US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico. The products were distributed to the following foreign countries: Antioquia, Australia, Bangkok, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican Republic, Ecuador, El Salvador, France, Germany, Guatemala, India, Indonesia, Japan, Korea, Kuwait, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.
- How much
- 152
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.
Z-3243-2018 · Class II · reported 2018-10-03 · Terminated
- Why it was recalled
- Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system
- Product
- Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
- Where it went
- Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
- How much
- 10 units
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.
Z-3242-2018 · Class II · reported 2018-10-03 · Terminated
- Why it was recalled
- Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system.
- Product
- Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
- Where it went
- Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
- How much
- 47 units
Showing the 30 most recent of 204. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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