Olympus recalls K-204 Guide Sheath Kits with inadequate sterile packaging seals that could lead to infections if used improperly. Affected kits may have partial heat seals causing non-sterile equipment.
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-204 Guide Sheath Kits 2.6MM due to a small percentage of sterile packages having inadequate seals. This could lead to infections if non-sterile equipment is used during medical procedures.
The kits have partial heat seals that may allow contaminants to enter the sterile packaging. If the seal is broken, the equipment could become non-sterile, increasing infection risk during medical procedures.
Healthcare professionals using the K-204 Guide Sheath Kit 2.6MM with endoscopes for respiratory tissue sampling. Patients at risk if the kit is used with compromised sterility.
Check for the model number K-204 on the kit. The kits were sold with endoscopes for respiratory tissue sampling and are labeled with model numbers like 01K through 9ZK.
Inspect the packaging for signs of a partial heat seal, which may indicate inadequate sterility.
The recall states a small percentage of kits have inadequate seals that could lead to infections, but not serious injury directly.
Look for the model number K-204 on the kit, which was sold with endoscopes for respiratory tissue sampling and has model numbers ranging from 01K to 9ZK.
The recall does not specify a remedy, so check the seal integrity and contact Olympus if you have concerns.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1053-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1053-2021 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.
