Olympus Recalls Single Use 3-Lumen Sphincterotome V Due to Potential Performance Loss
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Olympus Corporation of the Americas is recalling nearly 4,000 sphincterotome devices because a manufacturing defect may cause the instruments to deform 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 recall of the Single Use 3-Lumen Sphincterotome V. The recall was prompted by a manufacturing issue where certain devices did not undergo a required thermoforming process. According to the FDA, these affected instruments could potentially deform and lose performance during use.
Which Products Are Affected
The recall affects 3,954 units distributed worldwide, including nationwide across the United States. Affected states and territories include 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.
Product Details:
- Product Name: Single Use 3-Lumen Sphincterotome V
- Model/Catalog Number: KD-V411M-1520
- Material REF: (1) N5411630, (2) N1089910
- UDI-DI: (1) 04953170380600
- Affected Lots: All lots with a valid expiration date
- Recall Number: Z-1290-2026
What You Should Do
Olympus initiated the recall process by sending notification letters to affected customers on January 7, 2026. Healthcare providers and facilities should check their inventory for the specified model and material reference numbers. Any affected units should be handled according to the instructions provided in the firm's notification letter. For further information, consumers may contact Olympus Corporation of the Americas at their headquarters in Center Valley, Pennsylvania.
Why This Matters
These instruments are designed for use with endoscopes and guidewires during papillotomy procedures using high-frequency current. A device that deforms or loses performance during such a procedure could lead to surgical complications or the need for additional medical intervention.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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