Olympus Corporation Recalls Single Use 3-Lumen Sphincterotome V Due to Potential Performance Loss
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Olympus Corporation of the Americas has recalled 33,433 units of its Single Use 3-Lumen Sphincterotome V after discovering a manufacturing defect that may cause the device to deform.
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 Single Use 3-Lumen Sphincterotome V. The recall was prompted by the discovery that some devices did not undergo a necessary thermoforming process during manufacturing. As a result, these instruments could deform and lose performance during medical procedures.
Which Products Are Affected
The recall affects the Single Use 3-Lumen Sphincterotome V, designed for use with Olympus endoscopes and guidewires for papillotomy using high-frequency current.
- Model/Catalog Number: KD-V411M-0330
- Material REF Numbers: N1089530, N1089510, N5411230
- UDI-DI: 04953170380563
- Affected Lots: All lots with a valid expiration date
- Quantity: 33,433 units (36 in the United States; 33,397 distributed internationally)
- Geographic Scope: Distributed nationwide in the U.S. across 45 states and the District of Columbia, as well as international markets.
What You Should Do
Olympus Corporation of the Americas notified affected customers via a formal letter initiated on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the affected model and material reference numbers. For further information regarding returns or replacements, facilities may contact Olympus Corporation of the Americas at their headquarters located at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
Because these instruments are used in surgical procedures involving high-frequency current, a loss of performance or physical deformation of the device during use could compromise the safety and efficacy of the medical procedure.
Source
Information provided by the FDA under recall number Z-1271-2026.
Original source: FDA Official Notice ↗
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