Olympus recalls K-202 Guide Sheath Kit 2.0MM due to potential inadequate sterile packaging seals, which 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-202 Guide Sheath Kits 2.0MM because some sterile packages have poor seals that might cause infections. This is serious for medical procedures where sterile equipment is critical.
The kits have a small percentage of packages with partial heat seals, meaning the sterile packaging might not be intact. If non-sterile equipment is used during medical procedures, patients could develop infections.
Healthcare professionals using endoscopes to collect respiratory tissue samples are most at risk. Patients undergoing procedures with these kits could face infections if the seal fails.
Check for model number K-202 on the kit. Affected units include batch codes 01K through 9ZK as listed in the product description.
Inspect the kit for signs of a partial heat seal, which may indicate inadequate sterility.
Inspection found a small percentage of sterile packages with inadequate package seals, which could lead to infections if non-sterile equipment is used.
Model K-202 with batch codes 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK.
Check for model number K-202 and batch codes listed in the product description (01K through 9ZK).
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0971-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0971-2021 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.
