Olympus Endoscope Guide Sheath Recall Issued After Multiple Injuries Following Tip Detachment

Certain single use guide sheaths could detach from equipment inside patients during examinations.

Federal health officials have announced a recall of certain Olympus endoscope single use guide sheath kits, which have already led to dozens of serious injuries after the tips detached inside patients.

Endoscopes are thin, flexible tubes with a camera, which are usually inserted through the mouth, urethra or anus to help doctors see inside a patient’s body. They can help with the diagnosis of ulcers, inflammation, tumors and other illnesses. Guide sheaths are often used on them to minimize injury and provide stability during insertion.

However, the U.S. Food and Drug Administration (FDA) announced an Olympus endoscope guide sheath kit recall on February 28, indicating that the tips of certain Olympus endoscope guide sheaths used in the lungs and other breathing organs could detach while inserted into the patient’s body, leading to risks of severe injury or death.

Officials are warning that the tips of affected guide sheaths can break off during insertion or when excessive force is applied, potentially causing serious internal bleeding. Federal officials have received reports of at least 26 injuries related to endoscope guide sheaths detaching during insertion, though no deaths have been reported.

Olympus first sent an urgent medical device removal letter to all affected customers on January 15, indicating that Single Use Guide Sheath Kits with model numbers K-201, K-202, K-203 and K-204 have been recalled. Guide sheaths in the affected kits can be identified by the model numbers SG-200C and SG-201C.

Customers are being advised to immediately stop using the recalled products and separate them from other items. When the recall letter is received, it can be acknowledged by typing “6047” into the Olympus web portal.

Any organizations that are still in possession of the affected guide sheath kits can contact Olympus customer service at 1-800-848-9024 for a returned materials authorization form to receive company credit.

U.S. customers with additional questions should contact the Olympus Technical Assistance Center at 1-800-848-9024, option 1.

Olympus Endoscope Bacteria Alert

The recall of Olympus endoscope guide sheath kits is separate from a bacteria contamination alert issued earlier this year, which has been linked to 120 patient injuries and one death.

On December 23, 2024, the FDA issued a safety alert for Olympus MAJ-891 Endoscope forceps/irrigation plug components, warning that improper cleaning, sanitization, or disinfection after patient procedures can lead to serious infections, including urinary tract infections, sepsis and even death.

This alert follows a March 2023 FDA warning letter criticizing Olympus for failing to resolve ongoing quality issues with its duodenoscopes, specialized endoscopes used to access the small intestine.

These issues led to 160 patient complaints and were part of a broader safety concern identified in 2022, when the FDA found that nearly 7% of reusable duodenoscopes still contained high-risk bacteria even after cleaning. That discovery contributed to the industry’s shift toward disposable duodenoscopes to reduce infection risks.