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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

353

Class I (Serious)

22

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 901–920 of 3680 recalls

CAPIOX NX19 Oxygenator (Terumo) – Thermistor Bonding (2023)

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.

FDAMar 1, 2023Nationwide• Terumo Cardiovascular Systems Corporation

Leksell Stereotactic System Manuals (Elekta) – Incorrect IFU (2023)

The incorrect IFU was distributed with the devices.

FDAMar 1, 2023Nationwide• Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden

CAPIOX FX25 Oxygenator (Terumo) – Thermistor Bonding (2023)

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.

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High

FDAMar 1, 2023Nationwide• Terumo Cardiovascular Systems Corporation

Caspar Cervical Retractor (Aesculap) - Mislabeling (2023)

Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.

FDAFeb 23, 2023Nationwide• Aesculap Implant Systems LLC

Phenylephrine HCl Injection (Nephron) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 22, 2023Nationwide• Nephron Sterile Compounding Center LLC

Phenylephrine HCl Sodium Chloride (Nephron) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 22, 2023Nationwide• Nephron Sterile Compounding Center LLC

Phenylephrine HCl Injection (Nephron) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 22, 2023Nationwide• Nephron Sterile Compounding Center LLC

Phenylephrine HCl Injection (Nephron) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 22, 2023Nationwide• Nephron Sterile Compounding Center LLC

Norepinephrine Bitartrate Injection (Nephron) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 22, 2023Nationwide• Nephron Sterile Compounding Center LLC

Norepinephrine Bitartrate Injection (Nephron) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 22, 2023Nationwide• Nephron Sterile Compounding Center LLC

Norepinephrine Bitartrate Injection (Nephron) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 22, 2023Nationwide• Nephron Sterile Compounding Center LLC

Diltiazem HCl Injection (Nephron) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 22, 2023Nationwide• Nephron Sterile Compounding Center LLC

Carto Vizigo Guiding Sheath (Biosense Webster) - Incorrect Labeling (2023)

Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

FDAFeb 21, 2023Nationwide• Biosense Webster, Inc.

2D Perfusion (Philips) - Signal Processing (2023)

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

FDAFeb 20, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

SmartPerfusion (Philips) - Signal Processing (2023)

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

FDAFeb 20, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Paradise Grills Outdoor Kitchens – Fire hazard (2023)

This recall involves First Generation Paradise Grills Outdoor Kitchens. They can have cabinets, sinks, refrigerators, and other features such as LED lighting, Tiki Huts, commercial grills, granite and other additional options. The recalled models are the GX-3, GX-4, GX-5, GX-6, GX-7, GX-8, GX-9, GX-10, GX-11 GX12 and GX14, Tahiti, Fiji, Tropicana, Aruba 6 and Aruba 8. The model name is listed on the sales agreement.

CPSCFeb 16, 2023Nationwide• Paradise Grilling Systems Inc., of Ocoee, Florida

Flex-Neck Catheter Kit (Merit) - Unintended Distribution (2023)

Product that was built for design verification testing was inadvertently distributed to customers.

FDAFeb 15, 2023Nationwide• Merit Medical Systems, Inc.

Buprenorphine Patch (AVEVA) – impurity specification failure (2023)

Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

FDAFeb 15, 2023Nationwide• AVEVA Drug Delivery Systems, Inc.

Buprenorphine Transdermal System (AVEVA) – Substance Impurity Concerns (2023)

Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

FDAFeb 15, 2023Nationwide• AVEVA Drug Delivery Systems, Inc.

BEQ-HLS Medical Set (Maquet) – Packaging Sterility Concern (2023)

Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.

FDAFeb 13, 2023Nationwide• Maquet Medical Systems USA