Olympus Recalls Single Use 3-Lumen Sphincterotome V Due to Device Deformation Risk
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Olympus Corporation of the Americas has issued a voluntary recall for 1,025 units of its Single Use 3-Lumen Sphincterotome V due to a manufacturing defect that may cause device failure.
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, Devices.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of the Single Use 3-Lumen Sphincterotome V. The recall was triggered because certain devices did not undergo a necessary thermoforming process during manufacturing. This defect can cause the instruments to deform and lose performance during use.
Which Products Are Affected
The recall involves the following specific medical device:
- Product Name: Single Use 3-Lumen Sphincterotome V
- Model/Catalog Number: KD-V411M-3025
- Material REF: N1090210
- Code Information: All lots with a valid expiration date
- Quantity: 1,025 units (OUS only)
Distribution was worldwide, including nationwide in the United States across 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 began notifying customers of the issue via a letter sent on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the affected model and material reference numbers. Any affected units should be handled according to the instructions provided in the firm's notification letter. For further assistance, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
These instruments are used in specialized endoscopic procedures (papillotomy) involving high-frequency current. If a device deforms or fails to perform as intended during a procedure, it could lead to surgical complications or the need for additional medical intervention.
Source
This recall is documented by the FDA under recall number Z-1296-2026.
Original source: FDA Official Notice ↗
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