Olympus of the Americas recalls

32 recent recalls on record for Olympus of the Americas in connected official government data as of October 22, 2026 at 6:00 PM UTC.

Models with recalls

OER-ELITE Endoscope Reprocessor Connecting Tubes (12)Olympus 4K UHD LCD Monitor (1)Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector (1)Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector (1)Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector (1)Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector (1)Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 (1)Olympus Ellik Evacuator Includes Glass Body (1)Olympus Glass Body for 194 Ellik Evacuator (1)Olympus High Flow Insufflation Unit - UHI-4 (1)Olympus M3 Gold Autoclavable Foroblique Telescope 30 (1)Olympus M3 Gold Autoclavable Lateral Telescope 70 (1)Olympus Single Use Distal Cover (1)Olympus Thunderbeat II Shears w/Ultrasonic Mode (4)Olympus Toomey Evacuator 30cc with Adaptor (1)Olympus Toomey Evacuator 50cc with Adaptor (1)Olympus Tripp-Lite P580-025 25ft DisplayPort Cable (1)POWERSEAL 5 MM (in diameter) 23 CM (long) (1)

All Olympus of the Americas recalls

FDA Class II · Medical device · October 7, 2026

Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recall — Olympus Corporation of the Americas

While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.

Official ID Z-3329-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Olympus M3 Gold Autoclavable Lateral Telescope 70 recall — Olympus Corporation of the Americas

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Official ID Z-3300-2026 · Official record ↗

FDA Class II · Medical device · October 7, 2026

Olympus M3 Gold Autoclavable Foroblique Telescope 30 recall — Olympus Corporation of the Americas

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Official ID Z-3299-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector recall — Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Official ID Z-3247-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector recall — Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Official ID Z-3246-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector recall — Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Official ID Z-3245-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector recall — Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Official ID Z-3244-2026 · Official record ↗

FDA Class II · Medical device · September 30, 2026

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 recall — Olympus Corporation of the Americas

Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

Official ID Z-3216-2026 · Official record ↗

FDA Class II · Medical device · September 2, 2026

POWERSEAL 5 MM (in diameter) 23 CM (long) recall — Olympus Corporation of the Americas

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Official ID Z-3035-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Olympus High Flow Insufflation Unit - UHI-4 recall — Olympus Corporation of the Americas

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Official ID Z-2776-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Olympus 4K UHD LCD Monitor recall — Olympus Corporation of the Americas

Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.

Official ID Z-2761-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Glass Body for 194 Ellik Evacuator recall — Olympus Corporation of the Americas

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.

Official ID Z-2721-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Ellik Evacuator Includes Glass Body recall — Olympus Corporation of the Americas

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.

Official ID Z-2720-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Toomey Evacuator 50cc with Adaptor recall — Olympus Corporation of the Americas

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.

Official ID Z-2719-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

Olympus Toomey Evacuator 30cc with Adaptor recall — Olympus Corporation of the Americas

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.

Official ID Z-2718-2026 · Official record ↗

FDA Class II · Medical device · July 15, 2026

Olympus Single Use Distal Cover recall — Olympus Corporation of the Americas

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Official ID Z-2676-2026 · Official record ↗