Olympus recalls disposable triple lumen sphincterotomes that may deform and lose performance if not properly thermoformed. Affected models include KD-401Q-0320. No remedy specified in recall notice.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling disposable triple lumen sphincterotomes that could deform and lose performance if they didn't undergo proper thermoforming. This affects medical devices used during endoscopic procedures. The recall is for specific model numbers sold with valid expiration dates.
The devices may deform and lose performance if they did not undergo thermoforming. This could affect their function during endoscopic procedures like papillotomy using high-frequency current. However, the hazard does not indicate immediate injury risk.
Medical professionals who use Olympus disposable triple lumen sphincterotomes for endoscopic procedures are likely affected. Patients using these devices under a doctor's supervision are at minimal risk.
Check for model number KD-401Q-0320 on the device. The product was sold with valid expiration dates. This recall applies to specific medical instruments used with Olympus endoscopes.
Look for model number KD-401Q-0320 on the device to confirm if it's affected.
The recall states that devices without proper thermoforming may deform and lose performance, but no immediate injury risk is mentioned. Affected devices should be checked for model number KD-401Q-0320.
The recall does not specify a remedy, so no action is required beyond checking the model number.
Check for model number KD-401Q-0320 on the device. The product was sold with valid expiration dates.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1293-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1293-2026 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
