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Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp Recalls

All product recalls associated with Terumo Cardiovascular Systems Corp.

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Recall Summary

Total Recalls

1000

Past Year

898

Class I (Serious)

125

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 16141–16160 of 17592 recalls

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1 Integrated Centrifugal...

Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ''connect motor'' message to be displayed.

FDANov 8, 2006Nationwide• Terumo Cardiovascular Systems Corp

GE OEC Medical Systems, Inc: The Axcess Cranial Screw (sometimes referred to as the Ax...

GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insertion. There is a possibility that breaking of the screws could lead to a health hazard.

Class IIModerate

FDANov 8, 2006AL, CA, FL +5 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: The Axcess Cranial Screw (sometimes referred to as the Ax...

GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insertion. There is a possibility that breaking of the screws could lead to a health hazard.

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FDANov 8, 2006AL, CA, FL +5 more• GE OEC Medical Systems, Inc

Wilton Mitre Saws (WMH Tool Group) – Laceration Risk (2006)

Laceration Risk

The recall involves all Wilton-brand, 10-inch Compound Mitre Saws, including models with the Laser Line feature with model numbers 99164 and 99192. The model number is written on a black label on the motor housing.

CPSCNov 8, 2006Nationwide• WMH Tool Group Inc., (WMH), of Elgin, Ill.

Warn ATV Winch Kits – Overheating Risk (2006)

Fire/Burn Risk

This recall involves eight-post contactors used on certain 2,500 to 3,500 lb Warn ATV and Utility Vehicle Winch Kits. The black contactors were sold as a part of winch kits and have a "WARN" logo on the top and bottom of the contactor. Warn part number 62135 is printed on the bottom. Contactors are found on the vehicle attached to the power wires, between the battery and the winch. The contactor has four holes for securing it to the vehicle. A complete listing of winch kit part numbers involved in this recall can be found at www.warn.com

CPSCNov 8, 2006Nationwide• Warn Industries Inc., of Clackamas, Ore.

Smiths Medical PM, Inc.: BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Mon...

An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. - The ECG waveform may appear noisy, ECG readings appear accurate. -Respiration waveform may appear noisy and the respiration readings will be displayed as dashes.

FDANov 6, 2006PR• Smiths Medical PM, Inc.

Philips Medical Systems (Cleveland) Inc: Nuclear medicine systems: Gemini 16, Model 4535 679 289...

A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.

FDANov 6, 2006PR• Philips Medical Systems (Cleveland) Inc

Philips Medical Systems (Cleveland) Inc: Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilli...

A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.

FDANov 6, 2006PR• Philips Medical Systems (Cleveland) Inc

Beckman Coulter Inc: Expo32 ADC Software Version 1.1C, Part Number 6418337-New...

The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter.

FDANov 1, 2006Nationwide• Beckman Coulter Inc

Advanced Medical Optics, Inc.: AMO PhacoFlex Il Model SI40NB Intraocular Lenses

These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.

FDAOct 31, 2006Nationwide• Advanced Medical Optics, Inc.

Weil-McLain Ultra Series Boilers – Carbon Monoxide Hazard (2006)

Fire/Burn Risk

The recall involves Weil-McLain Ultra 80, Ultra 105, Ultra 155, Ultra 230 and Ultra 310 condensing, high-efficient, gas-fired boilers for space heating. The user's manual and installation manual have "Ultra Gas-Fired Water Boiler" on the cover. The boilers are wrapped in a glossy silver/flat black jacket and either stand on the floor or are wall-mounted. The serial numbers range from CP5071716 through CP5327000. When the panel on the front of the boiler is removed, a bar-coded label with the serial number is located on the lower right hand side of the boiler itself. "Weil-McLain" is written on the front panel of the boilers.

CPSCOct 31, 2006Nationwide• Weil-McLain, of Michigan City, Ind.

Beckman Coulter Inc: Access Immunoassay Systems Thyroglobulin Antibody Reagent...

Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.

FDAOct 26, 2006Nationwide• Beckman Coulter Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek Bone fragmentor Ref Number/Model ...

Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.

FDAOct 20, 2006Nationwide• Medtronic Sofamor Danek USA Inc

Continental Medical Labs, Inc: Fibrin Analysis Catheter Testing System includes the comp...

Fibrin Analysis Catheter Testying System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.

FDAOct 18, 2006IN, WI• Continental Medical Labs, Inc

Beckman Coulter Inc: FC 500 MPL Flow Cytometry System with MXP Software Versio...

The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.

FDAOct 17, 2006Nationwide• Beckman Coulter Inc

Quechua Tents and Canopies (Decathlon) – Flammability Risk (2006)

Fire/Burn Risk

All 2006 model Quechua branded tents (2-Seconds, 2-Seconds Air, 3-Seconds Air, T2, T3 Air, T4 Air, T6.2XL Air, T2 Ultralight Tents, T0 and T0+ canopies) sold in orange, red, blue, camouflage, or beige with SKU numbers 350808, 65196, 86813 146552, 146548, 100986, 351219, 370833, 531980, 531989, 65024, 90366, 90428, 567008, 567009, 567036, 567032, 370973, 22611, 566985, and 566992 are included in this recall. The SKU number can be found on the self-carry jacket. Quechua is printed on the exterior of the tent or canopy and on some of the carrying bags.

CPSCOct 17, 2006Nationwide• Decathlon USA, of Wilmington, Mass.

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

A 'battery needs service' message may be displayed, or the remaining battery time may incorrectly be reported out as zero, even when the battery is fully functional.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1, 4 inch diameter Rolle...

The roller pump will pause in response to a pressure alarm condition, as designed, but then may not resume operation as expected after the alarm condition has been cleared.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 6 inch diameter Rolle...

The large roller pump may experience false "overspeed' error message when starting rotation, which will prevent the pump from operating; until the condition is cleared by power cycling the roller pump.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

Pump may stop without an audible tone as a result of quickly clearing the internal pump alarm condition or overpressure alert/alarm condition.

FDAOct 16, 2006Nationwide• Terumo Cardiovascular Systems Corp