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Olympus Corporation of the Americas

Olympus Corporation of the Americas Recalls

All product recalls associated with Olympus Corporation of the Americas.

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Recall Summary

Total Recalls

709

Past Year

Class I (Serious)

Most Recent

Nov 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 121–140 of 709 recalls

ACMI Roller Bar Electrodes (Olympus) – Incorrect Pouch Labeling (2023)

Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

FDAOct 2, 2023AL, FL, GA +10 more• Olympus Corporation of the Americas

EVIS EXERA III Videoscope (Olympus) – Sterilization Failure (2023)

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

FDAOct 2, 2023Nationwide• Olympus Corporation of the Americas

Tracheal Intubation Fiberscope (Olympus) – Flow Rate Issue (2023)

Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

FDASep 28, 2023Nationwide

1...5 678 9...36

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• Olympus Corporation of the Americas

Insufflation Unit (Olympus) – Air Supply Stoppage (2023)

Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".

FDASep 25, 2023Nationwide• Olympus Corporation of the Americas

High-Flow Insufflation Unit (Olympus) – Cardiac Arrest Risk (2023)

There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.

FDASep 22, 2023Nationwide• Olympus Corporation of the Americas

EVIS EXERA III Video System (Olympus) – Power Supply Issue (2023)

Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.

FDASep 14, 2023Nationwide• Olympus Corporation of the Americas

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

FDASep 12, 2023Nationwide• Olympus Corporation of the Americas

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

FDASep 12, 2023Nationwide• Olympus Corporation of the Americas

Veran Percutaneous Biopsy Kit (Olympus) – Navigation System Issue (2023)

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

Veran Percutaneous Track Device (Olympus) – Navigation System Nonconformance (2023)

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

Veran Endobronchial Access Catheter (Olympus) – Navigation System Problem (2023)

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

Veran Endobronchial Needle (Olympus) – Navigation System Problem (2023)

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

Veran Thoracic Navigation System (Olympus) – Device Nonconformance (2023)

FDAAug 10, 2023Nationwide• Olympus Corporation of the Americas

Airway Mobilescope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Bronchovideoscope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

EVIS EXERA III Duodenovideoscope (Olympus) – infection risk (2023)

Recent reports of patient infection.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Tracheal Intubation Fiberscope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Visera Hysterovideoscope Olympus HYF Type V

IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

FDAJul 20, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: The Air/Water Valve is provided/used with the following E...

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

FDAJul 12, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas