Olympus Corporation Recalls Disposable Triple Lumen Sphincterotomes Over Performance Concerns
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Olympus is recalling over 7,600 Disposable Triple Lumen Sphincterotomes because a manufacturing error may cause the devices to deform and lose performance during use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 18, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its Disposable Triple Lumen Sphincterotome. The recall was prompted by the discovery that some devices did not undergo a necessary thermoforming process during manufacturing. As a result, these instruments may deform and lose performance while in use.
Which Products Are Affected
The recall affects the Disposable Triple Lumen Sphincterotome, specifically Model/Catalog Number KD-431Q-0720. These instruments are designed for use with Olympus endoscopes and guidewires for papillotomy procedures using high-frequency current.
Affected units include all lots with a valid expiration date associated with the following Material REFs and UDI-DIs:
- Material REF (1) 5859230: UDI-DI 04953170042362
- Material REF (2) N6221831: UDI-DI 04953170463778
- Material REF (3) N6221840: UDI-DI 04953170466564
A total of 7,689 units are impacted, including 7,501 units distributed across the United States and 188 units distributed internationally. Distribution in the U.S. includes AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
What You Should Do
Olympus notified customers of the issue via a formal letter initiated on January 7, 2026. Healthcare providers and facilities possessing these devices should check their inventory for the affected model and material reference numbers. Affected units should be sequestered and removed from service. For information regarding returns or replacements, contact Olympus Corporation of the Americas at their Center Valley, PA headquarters.
Why This Matters
The failure of these devices to perform as intended during a papillotomy could lead to procedural complications or loss of performance, as these instruments are critical for high-frequency current applications during endoscopic surgery.
Source
Information provided by the FDA under Recall Number Z-1270-2026.
Original source: FDA Official Notice ↗
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