Olympus Corporation of the Americas recalls

The Olympus Tripp-Lite P580-025 25ft DisplayPort Cable (Model P580-025) may cause video dropout or blackout when used with the OLYSENSE Hub System in high-power operating mode. About 543 cables were affected and distributed worldwide, including the US and Poland.

Moderate·FDA·Oct 7, 2026

Olympus is recalling two models of its M3 Gold autoclavable telescopes, 122 units in total. The sterilization settings in the English Instructions for Use do not match those in the Japanese package insert. The recall covers units distributed only in Japan, and no injuries have been reported.

Moderate·FDA·Oct 7, 20262 products

Olympus is recalling four BiCOAG Hemostasis Probe models because they may have been made without the full amount of adhesive, so the ceramic tip could detach. The recall covers 3,467 units sold in the US and several other countries. No injuries have been reported.

Moderate·FDA·Sep 30, 20264 products

Some Olympus EZDilate Endoscopic Balloon Dilator devices (Model BD-420X-1355) have an incorrect label on the shaft. The inflation chart label may show balloon sizes of 18, 19, or 20 mm when the actual device is 11, 12, or 13 mm. This mislabeling could lead to confusion during use.

Moderate·FDA·Sep 30, 2026

Olympus Corporation of the Americas is recalling POWERSEAL 5mm curved jaw sealer and divider devices due to incorrect labeling on the outer box. Some units labeled as 37 cm devices actually contain 23 cm devices, which could lead to confusion during surgical use. The issue affects 335 units distributed in the US, Australia, the European Union, and Japan.

Moderate·FDA·Sep 2, 2026

The Olympus UHI-4 insufflation unit may experience unexpected shutdowns where the front panel display turns off and air delivery stops during use. This affects about 3,087 units distributed worldwide. No injuries have been reported.

Moderate·FDA·Jul 29, 2026

Olympus has identified a potential fault in the HDMI and DisplayPort connectors on certain OEV321UH 4K UHD LCD Monitors. This fault can result in image loss or display abnormalities. The recall affects 10 units with specific serial numbers distributed in Ohio, California, New Jersey, Florida, and Japan.

Moderate·FDA·Jul 29, 2026

Olympus is recalling four evacuator products, including Toomey and Ellik models, because some sterilization instructions may not reliably make the devices fully sterile. The recall covers about 8,250 units distributed in the US and internationally.

Moderate·FDA·Jul 22, 20264 products

Olympus is recalling some SOLTIVE laser systems because a 24V power supply module may fail and make the system inoperable. The defect may also cause smoke or a burning smell, which is designed to stay inside the laser console and extinguish itself. No injuries have been reported. The recall covers 2 products, with 440 units affected, distributed in the US and several other countries.

Moderate·FDA·Apr 8, 20262 products

Olympus is recalling seven models of bipolar and PK/PKS cutting forceps, 3,788 units in total, used in medical procedures. The supplier did not adequately validate a welding process for components, and defective welds could cause the forceps' jaw to break during clinical use. No injuries have been reported.

Moderate·FDA·Apr 1, 20267 products

Olympus is recalling four endoscope products because the MAJ-1443 and MAJ-1444 valves are no longer compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. The recall covers about 139,000 units across the US, and no injuries have been reported.

Moderate·FDA·Apr 1, 20264 products

Olympus has identified a mis-wired component in certain ShockPulse-SE Lithotripsy System generators (model SPL-G) that can cause electrical noise in the ultrasonic circuit. This noise may reduce the system's reliability and delay treatment. The recall affects 55 units distributed internationally.

Moderate·FDA·Mar 11, 2026

Olympus is recalling two single-use biopsy valves, models MAJ-210 and MAJ-1218, which attach to the instrument channel port of compatible endoscopes. The valves may release rubber fragments during use. No injuries have been reported.

Moderate·FDA·Mar 11, 20262 products

Olympus is recalling three ShockPulse-SE lithotripsy system products, including the generator and reusable and single-use probes, with about 3,368 units affected. The generator can stay stuck in a blinking state and fail to recognize the transducer, which may be caused by damage to the transducer plug or generator receptacle. No injuries have been reported.

Moderate·FDA·Mar 11, 20263 products

Olympus is recalling 20 urological and gynecological resection sheath and inner sheath models sold across the US. The company received complaints that the ceramic tip of the resection sheath can break. No injuries have been reported, and the agency has not specified a remedy.

Moderate·FDA·Mar 4, 202620 products

Olympus is recalling the Cystoscope Outer Sheath model WA22810A because it is incompatible with GreenLight Laser systems used for prostate (BPH) treatment. Using this sheath with the laser can damage the tip of the device, potentially affecting the safety and function of the cystoscope.

Moderate·FDA·Mar 4, 2026

Olympus is removing 12 versions of its Thunderbeat surgical energy device from the market because it has continued to receive reports of adverse events. About 107,000 units are affected, and the devices were sold in the US and in Brazil, Canada, Germany, Mexico, and Japan. The recall notice does not list any reported injuries.

Moderate·FDA·Feb 25, 202612 products

Olympus Corporation is recalling the High Flow Insufflation Unit (Model UHI) used during abdominal surgery due to a software problem that may cause overpressure events. The device is used to inflate the abdominal cavity and remove smoke during laparoscopic surgery. No injuries have been reported.

Serious·FDA·Feb 25, 20263 products

Olympus is recalling 30 sphincterotome devices, which are used with an endoscope during medical procedures. Some units were not thermoformed as required and could deform, losing performance. No injuries have been reported.

Moderate·FDA·Feb 11, 202630 products

Olympus Corporation is recalling certain single-use electrosurgical knives (model KD-640L) used during endoscopic surgery. The cutting knife can overheat, burn, and break during use, which could affect the surgery. No injuries have been reported.

Moderate·FDA·Feb 11, 20262 products

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

FDA·Dec 3, 2025

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

FDA·Dec 3, 2025

Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.

FDA·Nov 26, 2025

Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.

FDA·Nov 19, 20252 products

The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.

FDA·Nov 19, 2025