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Olympus Corporation of the Americas Recalls
414 recalls on record · October 7, 2015 to July 29, 2026 · Medical Devices
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Hazard: Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
July 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displayi
Hazard: Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
July 22, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Hazard: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
July 22, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Hazard: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
July 22, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Hazard: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
July 22, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Hazard: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
July 15, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designe
Hazard: Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Hazard: XXX
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OE
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Hazard: Potential for detachment of a distal tip component of the device during use.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Hazard: Potential for detachment of a distal tip component of the device during use.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Hazard: Potential for detachment of a distal tip component of the device during use.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Hazard: Potential for detachment of a distal tip component of the device during use.
April 8, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog
Hazard: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
April 8, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/
Hazard: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Pr
Hazard: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 92000
Hazard: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Prod
Hazard: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HA
Hazard: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Pro
Hazard: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.