Olympus Corporation Recalls Disposable Triple Lumen Sphincterotomes Due to Potential Device Deformation
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Olympus Corporation of the Americas has initiated a voluntary recall of specific Disposable Triple Lumen Sphincterotomes that may deform and lose performance during medical procedures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 18, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Olympus Corporation of the Americas has issued a voluntary, firm-initiated recall for its Disposable Triple Lumen Sphincterotome. The recall was prompted by the discovery that certain devices did not undergo the required thermoforming process. Consequently, these instruments could potentially deform and lose performance during use.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: Disposable Triple Lumen Sphincterotome
- Model/Catalog Number: KD-411Q-0720
- Material REF: 5858030
- Affected Lots: All lots with a valid expiration date
- Quantity: 125 units (7 in the United States, 118 international units)
These instruments are designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. The distribution scope includes international locations and U.S. nationwide distribution across 44 states and territories, 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.
What You Should Do
The firm began notifying customers via letter on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for Model KD-411Q-0720. Affected units should be sequestered to prevent use. For information regarding the return or replacement of these devices, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034-8229.
Why This Matters
Because these devices are used in surgical procedures involving high-frequency current, any deformation or loss of performance could compromise the precision of the papillotomy and potentially impact patient safety during the procedure.
Source
Information provided by the FDA under Recall Number Z-1285-2026.
Original source: FDA Official Notice ↗
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