Olympus Recalls Disposable Triple Lumen Sphincterotome Due to Potential Deformation and Performance Loss
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Olympus Corporation of the Americas has issued a voluntary recall for its Disposable Triple Lumen Sphincterotome after discovering manufacturing defects that could 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 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 its Disposable Triple Lumen Sphincterotome. The recall was prompted by the discovery that certain 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 involves the following medical device:
- Brand Name: Disposable Triple Lumen Sphincterotome
- Model/Catalog Number: KD-401Q-0320
- Material REF: 5856630
- UDI-DI: 04953170041587
- Affected Lots: All lots with a valid expiration date
- Quantity: 999 units
These instruments are designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. The distribution of these products is worldwide, including nationwide distribution across the United States in 44 states, the District of Columbia, and Guam.
What You Should Do
Olympus initiated the recall notification via letter on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the affected model number (KD-401Q-0320). If affected units are found, users should follow the specific instructions provided in the firm's notification letter regarding the handling and return of the devices. For further information, facilities may contact Olympus Corporation of the Americas at their Center Valley, PA headquarters.
Why This Matters
This recall is classified as a Class II event by the FDA. Because these devices are used in surgical procedures involving high-frequency current, any deformation or loss of performance could lead to complications during the papillotomy, potentially impacting patient safety and procedural success.
Source
This information is based on official recall data provided by the FDA under recall number Z-1293-2026.
Original source: FDA Official Notice ↗
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