Dive Brief:

• Olympus has recalled endoscope guide sheath kits after receiving 26 reports of serious injuries linked to the devices.
• The Food and Drug Administration, which published a Class I recall notice Friday, said the tip of the guide sheath has detached from some devices and fallen off in the patient.
• Olympus has asked customers to stop using the affected devices. The company discontinued the products in the U.S. in 2022 and is now removing the models from the American market.

Dive Insight:

The recall affects Olympus’ K-201, K-202, K-203 and K-204 single use guide sheath kits. Physicians use the devices with Olympus endoscopes to collect cells and tissue specimens from peripheral regions of the lungs. The sheaths have a radiopaque tip that enables healthcare professionals to see the end of the device on the X-ray monitor.

In January, Olympus sent an urgent medical device removal notice to tell customers about a potential problem with the devices. The company received 32 complaints about the tip falling off in patients during surgery between July 2021 and January 2025. The complaints included 26 serious injuries and six malfunctions.

The FDA said there have been no reports of death. However, the products could cause serious adverse health consequences including bleeding and death, the agency said, and as such the FDA classified the event as the most serious type of recall. Olympus said medical interventions may be needed to remove detached tips, adding that the issue could cause procedure delays and cancellations.

Olympus’ investigation found the separation of the tip from the rest of the device is likely the result of healthcare professionals using excessive force when inserting instruments into the guide sheath. Damage to the distal end of the sheath, where the radiopaque tip is attached, could also be a factor.

Olympus has asked customers to stop using the devices immediately. Customers can return the products in exchange for credit with Olympus. The company is removing the four affected models from the U.S. market and focusing on its next-generation sheaths, K-401 and K-402. The latest models have a different radiopaque tip design.

The removal of the products comes less than 18 months after Olympus stopped selling electromagnetic navigation systems used in biopsies of the peripheral regions of the lungs. Olympus acquired the devices in its $300 million takeover of Veran Medical Technologies but later suspended shipments and recalled products because of quality problems.