Olympus Recalls Disposable Triple Lumen Sphincterotome Due to Potential Device Deformation
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Olympus Corporation of the Americas has recalled 887 Disposable Triple Lumen Sphincterotomes because units that skipped thermoforming may deform and lose performance during use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references Worldwide. 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its Disposable Triple Lumen Sphincterotome. The recall was triggered after it was discovered that certain devices did not undergo a necessary thermoforming process. According to the FDA, these instruments could potentially deform, which may lead to a loss of performance during medical procedures.
Which Products Are Affected
The recall affects the following medical device:
- Product Name: Disposable Triple Lumen Sphincterotome
- Model/Catalog Number: KD-411Q-0730
- Recall Number: Z-1286-2026
- Material REFs: 5858230, N6221731, N6221740
- UDI-DI: 04953170466557
- Quantity: 887 units total (650 in the U.S.; 237 internationally)
- Scope: All lots with a valid expiration date are included.
Distribution in the United States includes the following states and territories: 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 facilities and providers should check their inventory for Model KD-411Q-0730 and follow the instructions provided in the firm's notification letter. For additional information or questions regarding the return of affected units, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
These instruments are designed for use with endoscopes and guidewires for papillotomy using high-frequency current. If the device deforms during a procedure, it could fail to perform as intended, potentially complicating the surgical intervention.
Source
Information provided by the FDA under Recall Event ID 98252.
Original source: FDA Official Notice ↗
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