Olympus Recalls Disposable Triple Lumen Sphincterotomes Due to Potential Performance Loss
Olympus Corporation of the Americas has issued a voluntary recall for certain Disposable Triple Lumen Sphincterotomes that may deform and lose performance during medical procedures.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its Disposable Triple Lumen Sphincterotome. The recall was prompted by a manufacturing issue where certain devices did not undergo the necessary thermoforming process. As a result, these instruments could deform, potentially leading to a loss of performance during use.
Which Products Are Affected
The recall affects the following medical device:
- Product Name: Disposable Triple Lumen Sphincterotome
- Model/Catalog Number: KD-401Q-0330
- Material REF: 5856730
- UDI-DI: 04953170041617
- Affected Lots: All lots with a valid expiration date
Approximately 886 units are affected. The distribution of these products is worldwide, including nationwide distribution in the United States across 45 states, the District of Columbia, and Guam.
What You Should Do
Olympus initiated the recall notification via letter on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the affected Model/Catalog Number KD-401Q-0330. Any units identified from the affected lots should be handled according to the instructions provided in the firm’s notification letter. For additional information, facilities may contact Olympus Corporation of the Americas at their headquarters in Center Valley, Pennsylvania.
Why This Matters
These instruments are designed for use with endoscopes and guidewires during papillotomy procedures using high-frequency current. A device that deforms or loses performance during such a procedure could compromise the effectiveness of the treatment or lead to surgical complications.
Source
Source: FDA Official Notice