Olympus Recalls Single Use 3-Lumen Sphincterotome V Due to Potential Device Deformation
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Olympus Corporation of the Americas has issued a voluntary recall for over 136,000 sphincterotome units because a manufacturing omission could cause the devices to 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 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, MedicalDevices.
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 the discovery that certain devices did not undergo a required thermoforming process. According to the FDA, these affected instruments could potentially deform, leading to a loss of performance during medical procedures.
Which Products Are Affected
The recall affects a total of 136,037 units, including 9,959 units distributed in the United States and 126,078 units distributed internationally.
- Product Name: Single Use 3-Lumen Sphincterotome V
- Model/Catalog Number: KD-V411M-0725
- Material REF: (1) N1089710, (2) N5411430
- UDI-DI: 04953170380587
- Affected Lots: All lots with a valid expiration date
- Recall Number: Z-1273-2026
The product was distributed nationwide across the United States, including 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, as well as internationally.
What You Should Do
Olympus initiated the recall by sending notification letters to affected customers. Healthcare facilities and providers should immediately check their inventory for the specified model and material reference numbers. If you possess affected units, follow the instructions provided in the firm's notification letter regarding the handling or return of the devices.
Why This Matters
These instruments are designed for use with Olympus endoscopes and guidewires for papillotomy using high-frequency current. A loss of performance or device deformation during such a procedure could impact the safety and efficacy of the medical intervention.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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