Olympus recalls K-203 Guide Sheath Kit 2.6MM due to potential infection from inadequate sterile packaging seals. Affected units include specific model numbers sold in certain regions.
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-203 Guide Sheath Kits 2.6MM because some sterile packages have weak seals that could lead to infections if used improperly. This affects patients undergoing endoscopic procedures.
The sterile packaging may have partial heat seals, meaning the kit could become non-sterile. If non-sterile equipment is used during procedures, patients might develop infections.
Patients using this kit for endoscopic procedures in respiratory organs are most at risk. The recall applies to specific model numbers sold in certain regions.
Check for model numbers 01K through 9ZK on the kit packaging. These kits are used with endoscopes to collect respiratory tissue samples.
Inspect the packaging for partial heat seals that may compromise sterility.
No, this kit is used with endoscopes to collect cells or tissue from respiratory organs during procedures.
Look for model numbers 01K through 9ZK on the packaging. These kits are used with endoscopes for respiratory tissue collection.
The recall does not require immediate stop use; check for seal integrity before use.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0972-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0972-2021 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.
