Olympus recalls single-use sphincterotome devices that may deform without proper thermoforming, risking loss of performance during medical procedures.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling single-use sphincterotome devices that could deform and lose performance if not properly thermoformed. This affects medical use where precise function is critical.
The devices require thermoforming to maintain proper shape and function. If not thermoformed correctly, they may deform and lose performance during medical procedures, potentially affecting surgical outcomes.
Medical professionals using these devices for endoscopic procedures. Patients receiving the device during surgery are at risk if the device deforms during use.
Check for model number KD-VC433Q-0720 on the device. These were sold with valid expiration dates and used with Olympus endoscopes for papillotomy procedures.
Look for model number KD-VC433Q-0720 on the device label.
The devices could deform and lose performance if not properly thermoformed, which may affect surgical outcomes.
No specific stop-use instruction is provided; the recall focuses on proper thermoforming for function.
Check for model number KD-VC433Q-0720 on the device label, which was sold with valid expiration dates for endoscopic procedures.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1283-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1283-2026 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.
