Olympus Recalls Single Use 3-Lumen Sphincterotome V Over Performance Concerns
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Olympus Corporation of the Americas is recalling 30,489 units of its Single Use 3-Lumen Sphincterotome V because devices that did not undergo thermoforming could deform and lose performance.
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.
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What Happened
Olympus Corporation of the Americas has initiated a voluntary Class II recall of its Single Use 3-Lumen Sphincterotome V. The recall was prompted by the discovery that certain devices did not undergo a required thermoforming process. As a result, these instruments could deform, leading to a loss of performance during medical procedures.
Which Products Are Affected
The recall affects a total of 30,489 units, including 11,779 units distributed in the United States and 18,710 units distributed internationally.
- Product Name: Single Use 3-Lumen Sphincterotome V
- Model/Catalog Number: KD-V431M-0720
- Material REFs: (1) N1090410, (2) N1090430, (3) N5411930
- UDI-DI: 04953170184178
- Recall Number: Z-1275-2026
- 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 facilities and distributors should check their inventory for the affected model and catalog numbers listed above. Users should follow the specific instructions provided in the firm's notification letter regarding the handling and return of affected products.
Why This Matters
These instruments are designed for use with endoscopes and guidewires for papillotomy using high-frequency current. If the device deforms due to the lack of thermoforming, it may fail to perform as intended during these sensitive medical procedures, potentially impacting patient safety.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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