Olympus recalls K-201 Guide Sheath Kit 2.0mm due to potential inadequate sterile packaging, which could lead to infections if used improperly. 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 its K-201 Guide Sheath Kit 2.0mm because some sterile packages have poor seals. This could let bacteria enter the body during medical procedures, risking infections for patients.
The sterile packaging may not seal properly, allowing contaminants to enter the kit. If the kit is used without a proper seal, it could lead to infections during medical procedures.
Patients using this kit for respiratory tissue sampling may be at risk if the kit's seal is compromised. Healthcare providers who use the kit for endoscopic procedures are most affected.
Check for model number K-201 on the kit. The kit is sold in specific regions with model numbers like 01K through 9ZK.
Inspect the packaging for signs of poor sealing, such as gaps or discoloration.
The recall states a risk of infection if non-sterile equipment is used, but does not mention serious injury or death.
Look for model number K-201 with specific regional codes like 01K through 9ZK on the packaging.
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-1050-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1050-2021 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.
