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Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation Recalls

All product recalls associated with Terumo Cardiovascular Systems Corporation.

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Recall Summary

Total Recalls

1000

Past Year

582

Class I (Serious)

Most Recent

Dec 2025

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 9001–9020 of 10937 recalls

Terumo Cardiovascular Systems Corporation: Sarns Centrifugal Pump (without X-coating), catalog 16427...

The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.

FDAJul 6, 2009Nationwide• Terumo Cardiovascular Systems Corporation

Philips Medical Systems North America Co. Phillips: EasyDiagnost

The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch

FDAJul 6, 2009Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: UroDiagnost

The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch

1...449 450451452 453...547

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FDAJul 6, 2009Nationwide• Philips Medical Systems North America Co. Phillips

Phillips Nuclear Medicine: BrightView Gamma Camera Radius Drive Assembly, manufactur...

Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.

FDAJul 2, 2009Nationwide• Phillips Nuclear Medicine

Medtronic Neuromodulation: Medtronic SynchroMed II Programmable Pump, 8637, Rx Only,...

This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed II pumps with batteries manufactured during two distinct time periods prior to April 2005. Nature of the Device Issue: As part of ongoing analysis of returned explanted product, Medtronic has confirmed that reduced battery performance resulted in eight (8) occurrence

FDAJul 1, 2009DC, PR• Medtronic Neuromodulation

Rope Cutters (MarineTech) – Fire Risk (2009)

Fire/Burn Risk

The recalled tabletop rope cutters are used for cutting and cauterizing rope. This recall includes MarineTech part number 75-7070 and West Marine part number 559419. The Marine Tech part number is located on the side of the rope cutter. "Panther" is printed on the rope cutter.

CPSCJul 1, 2009Nationwide• MarineTech Products Inc., of White Bear Lake, Minn.

Snowmobiles (Polaris) – Control Loss (2009)

This recall involves 2009 Polaris 800 Assault RMK 146 snowmobiles model numbers S09PL8EE and S09PL8ES. "Assault 800" is printed on the snowmobile's hood. "Polaris" is written on the seat. The model number is located on the right side of the tunnel below the seat. The snowmobiles are red and black.

CPSCJul 1, 2009Nationwide• Polaris Industries Inc., of Medina, Minn.

Ionic Salt Lamps – Fire Hazard (2009)

Fire/Burn Risk

The recalled ionic salt lamp varies in color from light to dark red and is attached to a wood base. The lamp fixture comes with a 10 watt bulb and a black cord with an inline on/off switch. The UL file number E216832 will be printed on the cord and the UL file number E214389 on the plug.

CPSCJul 1, 2009Nationwide• Fashion Stitches & More, Inc., of Dayton, N.J.

Medtronic MiniMed: Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397...

Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered.

FDAJun 29, 2009Nationwide• Medtronic MiniMed

Mattress Sets (Loyal Bedding) – Flammability Issue (2009)

Fire/Burn Risk

This recall involves all Loyal Bedding mattress sets (Mattresses and Mattresses with Foundations). They were sold in twin, full, queen, and king sizes. "Loyal Bedding" and "Classic Rest", "Designer Collection", or "Smart Loyal" are printed on a label at the foot of the top of the mattress.

CPSCJun 25, 2009Nationwide• Loyal Bedding Inc., of Miami, Fla.

GE OEC Medical Systems, Inc: OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); I...

GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.

FDAJun 22, 2009Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); I...

Class IHigh

FDAJun 22, 2009Nationwide• GE OEC Medical Systems, Inc

Breg Inc, An Orthofix Company: Power Supply Accessory (model AD-0660G) Power supply acc...

Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip.

FDAJun 18, 2009Nationwide• Breg Inc, An Orthofix Company

Battery Equalizers (SmartSpark) – Fire Risk (2009)

Fire/Burn Risk

The recalled battery equalizers are charge balancing devices designed to increase the performance and longevity of rechargeable batteries.

CPSCJun 18, 2009Nationwide• SmartSpark Energy Systems Inc., of Champaign, Ill.

Generic Medical Devices: GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product...

Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.

FDAJun 18, 2009NJ, PA• Generic Medical Devices

Built-In Refrigerators (Viking) – detaching door risk (2009)

This recall involves Viking built-in 48-inch wide side-by-side refrigerator/freezers and the built-in 36-inch wide refrigerators with bottom freezers with model and serial numbers with date codes listed below. The refrigerators come in stainless steel and various colors and wood finishes and are built into the kitchen cabinetry. "Viking" is written on the front of the refrigerator. The model and serial numbers are located either behind the produce drawer or on the ceiling of the interior of the refrigerators. The 42-inch wide or freestanding refrigerators are not included in this recall. Model Numbers Starting With Date Codes VCSB481, VCSB482, DDSB482, DFSB482 DTSB482, DDBB362, VCBB360, VCBB362 DFBB362, DTBB362, DTBB363 All units VCSB483, DDSB483, DFSB483, DTSB483 Date codes before 030104 VCSB483D, DDSB483D, DFSB483D Date codes before 030105 VCBB363 Date codes before 111605 DDBB363 Date codes before 112305 DFBB363 Date codes before 041006 The first six numbers in the serial number are the manufacture date of the unit in [mm][dd][yy] format, e.g., serial number 051903G0000000375 was manufactured on May 19, 2003 and serial number F01250210170 was manufactured on January 25, 2002.

CPSCJun 16, 2009Nationwide• Viking Range Corporation, of Greenwood, Miss.

Computerized Medical Systems Inc: Focal Radiation Treatment Planning System, Focal Release...

Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.

FDAJun 12, 2009Nationwide• Computerized Medical Systems Inc

Becton Dickinson and Company: BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. B...

Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.

FDAJun 12, 2009Nationwide• Becton Dickinson and Company

Orthosoft, Inc. dba Zimmer CAS: NDI P7 Position Sensor, Stereotaxic Instrument

Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.

FDAJun 9, 2009FL, IN, KS +5 more• Orthosoft, Inc. dba Zimmer CAS

Orthosoft, Inc. dba Zimmer CAS: NDI P7 Position Sensor, Stereotaxic Instrument

Class IIModerate

FDAJun 9, 2009FL, IN, KS +5 more• Orthosoft, Inc. dba Zimmer CAS