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SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku Recalls

All product recalls associated with SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku.

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

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 661–680 of 3680 recalls

Trinias Angiography System (Shimadzu) – Flat Panel Malfunction (2024)

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

Moderate

FDAJan 29, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Vantage Elan MRI (Canon) – SFG Value Mismatch (2024)

For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.

Moderate

FDAJan 29, 2024Nationwide• Canon Medical System, USA, INC.

Vantage MRI Systems (Canon) – SFG Value Mismatch (2024)

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Moderate

FDAJan 29, 2024Nationwide• Canon Medical System, USA, INC.

Embrace Drill Tower (Waldemar Link) – Technique Description Mix-up (2024)

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

Low

FDAJan 29, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Embrace Drill Tower (Waldemar Link) – Technique Description Mix-up (2024)

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

Low

FDAJan 29, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Vantage Titan MRI (Canon) – SFG Value Mismatch (2024)

Moderate

FDAJan 29, 2024Nationwide• Canon Medical System, USA, INC.

BiMobile Dual Mobility System (Waldemar Link) – Mislabeling Risk (2024)

Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

Low

FDAJan 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

HLS Set Advanced (Maquet) – Sterile Barrier Compromise (2024)

The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

High

FDAJan 16, 2024Nationwide• Maquet Medical Systems USA

HLS Set Advanced (Maquet) – Sterile Barrier Compromise (2024)

The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

High

FDAJan 16, 2024Nationwide• Maquet Medical Systems USA

Vasostrict (Par Sterile Products) – Superpotent Drug (2024)

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

Class IIModerate

FDAJan 11, 2024Nationwide• Par Sterile Products LLC

Western Star 6900 (Western Star) – Parking Brake Defect (2024)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2023 Western Star 4900 and Western Star 6900 vehicles. A defect in the inversion valve may delay park brake engagement, which could allow the vehicle to move unintentionally. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 121, "Air Brake Systems."

High

NHTSAJan 10, 2024Nationwide• WESTERN STAR

Abbott Reproductive Control Set (McKesson) – Temperature Excursion (2024)

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

Moderate

FDAJan 9, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Abbott i-STAT Control (McKesson) – Temperature Excursion (2024)

Moderate

FDAJan 9, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

VOCSN Patient Breathing Package (Ventec) – Spiral Wrap Failure (2024)

The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients.

Very High

FDAJan 9, 2024CA, CO, FL +5 more• Ventec Life Systems, Inc.

OSOM BVBLUE Control Kit (Mckesson) – Temperature Excursion Risk (2024)

Moderate

FDAJan 9, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Endo Cleaning Indicator (Mckesson) – Temperature Excursion Risk (2024)

Moderate

FDAJan 9, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

RotaFlow Centrifugal Pump (Maquet) – Sterile Barrier Risk (2024)

Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.

High

FDAJan 8, 2024Nationwide• Maquet Medical Systems USA

RotaFlow Centrifugal Pump (Maquet) – Sterile Barrier Risk (2024)

High

FDAJan 8, 2024Nationwide• Maquet Medical Systems USA

Allura Xper X-ray Systems (Philips) – Framegrabber Performance Issue (2024)

Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.

Moderate

FDAJan 2, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Bubble Sensor (Maquet) – UDI Identifier Problem (2023)

The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

Low

FDADec 28, 2023AZ, CA, CO +10 more• Maquet Medical Systems USA