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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

144

Past Year

Class I (Serious)

Most Recent

Oct 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 101–120 of 144 recalls

Olympus Corporation of the Americas: Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-M...

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

Moderate

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.

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

Moderate

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.

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

Moderate

1...4 567 8

Page 6 of 8Next

FDA

Jul 27, 2023

Nationwide

• Olympus Corporation of the Americas

Olympus Corporation of the Americas: EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

Recent reports of patient infection.

Moderate

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.

Moderate

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.

Moderate

FDAJul 12, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150,...

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

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-X...

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

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, ...

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

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: HF Resection Electrodes - HF resection electrodes are par...

Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

Moderate

FDAJun 8, 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.

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Numbe...

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

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Nu...

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

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model N...

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

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- ...

Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

Moderate

FDAMay 26, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Olympus Endoscope Reprocessor OER-Pro-For use in cleaning...

Moderate

FDAMay 26, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used w...

Moderate

FDAMay 26, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: UroPass Ureteral Access Sheaths, 5 pieces/box

Dilator tips may break in the package and in patients during surgical procedures.

Moderate

FDAMay 19, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Always-On Tip Tracked Instruments (SPiN Drive instruments...

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

Moderate

FDAMay 15, 2023Nationwide• Olympus Corporation of the Americas

Olympus Corporation of the Americas: Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX...

Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

Moderate

FDAMay 4, 2023Nationwide• Olympus Corporation of the Americas