Olympus Recalls Single Use Sphincterotome V Due to Potential Performance Failure
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Olympus Corporation of the Americas is recalling over 12,000 Single Use Sphincterotome V devices because they may deform and lose performance during medical procedures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 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 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 Class II recall of its Single Use Sphincterotome V (Distal Wire guided). The recall was issued because certain devices did not undergo a necessary thermoforming process. As a result, these instruments could deform and lose performance during use, potentially impacting medical procedures.
Which Products Are Affected
The recall involves the Single Use Sphincterotome V (Distal Wire guided), specifically Model/Catalog Number KD-VC431Q-0720.
Details for identification include:
- Material REFs: N5391530, N5391510, N5777830
- UDI-DI: 04953170466427
- Quantity: 12,641 units (8,789 in the U.S.; 3,852 internationally)
- Affected Lots: All lots with a valid expiration date
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 initiated the recall notification via letter 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 to prevent use. For further instructions regarding the return or replacement of these devices, contact Olympus Corporation of the Americas at their headquarters in Center Valley, PA.
Why This Matters
These instruments are designed for use with Olympus endoscopes and guidewires for papillotomy using high-frequency current. A device that deforms or loses performance during such a procedure could lead to surgical complications or ineffective treatment.
Source
Information provided by the FDA (Recall Number: Z-1269-2026).
Original source: FDA Official Notice ↗
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