Olympus recalls K-201 Guide Sheath Kit 2.0MM due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units include specific model numbers and batch codes.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Olympus is recalling K-201 Guide Sheath Kits 2.0MM because some sterile packages have weak seals that could allow infections if used improperly. This is a serious risk for medical procedures involving endoscopes.
The sterile packaging has a partial heat seal in some units, meaning the seal might not hold properly. If the seal fails, the kit could become non-sterile, increasing the risk of infections during medical procedures.
Healthcare professionals using endoscopes for respiratory tissue sampling may be affected. Patients undergoing procedures with this kit are at risk of infection if the seal is compromised.
Check for model number K-201 on the kit. Affected units include batch codes 01K through 9ZK as listed in the recall notice.
Inspect the packaging for signs of a partial heat seal, which may indicate a compromised seal.
Reach out to Olympus directly for guidance on whether the kit is affected and next steps.
The recall states a risk of infection if non-sterile equipment is used, but does not mention injuries directly.
Check for model number K-201 and batch codes 01K through 9ZK as listed in the recall notice.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0970-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0970-2021 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.
