Olympus Corporation of the Americas recalled 886 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall follows reports that devices not properly thermoformed could deform and lose performance. Patients and healthcare providers should stop using the device immediately.
Devices which did not undergo thermoforming could deform and lose performance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Disposable Triple Lumen Sphincterotome is a medical device used in endoscopic procedures for papillotomy with high-frequency current. Healthcare providers commonly use this instrument to facilitate procedures requiring precise access to the bile duct.
The devices may lose their performance due to inadequate thermoforming, leading to potential malfunction during use. This poses a risk to patient safety during medical interventions.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers who rely on this device for critical procedures. The potential for device malfunction could lead to complications during surgery, urging immediate action.
The model number and expiration date are typically located on the device packaging or the device itself, often printed or labeled clearly.
Expect a refund or replacement processing timeframe of 4-6 weeks after submission.
Keep copies of receipts, any correspondence with the manufacturer, and photos of the device for your records.
The recalled product is the Disposable Triple Lumen Sphincterotome with model number KD-401Q-0330. It was distributed worldwide, including all 50 US states. The devices are designed for use with Olympus endoscopes and guidewires.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Olympus recalls 408 SOLTIVE Premium Laser System units worldwide after a defect in the 24V power supply may render the system inoperable and cause smoke or a burning smell. The issue is contained within the internal console and would self-extinguish. Hospitals should stop using the device immediately and follow recall instructions.
Olympus Corporation of the Americas recalled 164 Everest Bipolar Cutting Forceps worldwide on Feb. 25, 2026. A supplier welding process was not adequately validated, risking jaw breakage during surgical use. Clinicians should stop using the device and follow Olympus recall instructions.
Olympus Corporation of the Americas recalled 93 PKS Cutting Forceps worldwide due to welding defects that can cause the jaw to break during clinical use. The issue involves Model 3005PK and UDI 00821925036000. Action is required immediately and providers should follow recall instructions.
Olympus Corporation of the Americas is recalling 106 Everest Bipolar Cutting Forceps worldwide. The devices can have welding defects that may cause the jaw to break during use. Stop using immediately and contact Olympus or your healthcare provider for instructions.
Olympus Corporation of the Americas recalled 326 PKS Cutting Forceps worldwide. The devices may have welding defects that cause the jaw to break during use. Stop using the device immediately and follow the recall instructions provided by Olympus.
Olympus Corporation of the Americas is recalling 2,648 HALO PKS Cutting Forceps HACF0533 sold to hospitals and clinics worldwide. The jaw can break during surgical use due to a supplier welding-validation issue. Healthcare facilities should stop using the device immediately and follow Olympus recall instructions for disposition.
Olympus recalls 7 PKS Cutting Forceps worldwide because welded components may fail. The devices are used with a 5mm cannula and an electrosurgical generator. Stop using the device and follow the manufacturer’s recall instructions. Healthcare facilities should verify device details and consult Olympus for replacement options.
Olympus Corporation of the Americas is recalling 444 PK-CF0533 cutting forceps distributed worldwide. The devices may have welding defects that can cause the jaw to break during surgery. Stop using the device and follow recall instructions from Olympus or your healthcare provider.