Olympus recalls K-204 Guide Sheath Kit 2.6MM (model K-204) due to potential infection from inadequate sterile packaging seals. Affected units sold in specific batches.
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 because some sterile packages have weak seals that could lead to infections if used improperly. This affects patients who use the kits during endoscopic procedures.
The sterile packaging has partial heat seals in some units, meaning the kit might not be sterile when opened. If non-sterile equipment is used during endoscopy, patients could develop infections.
Patients using the K-204 Guide Sheath Kit 2.6MM with endoscopes for respiratory tissue sampling are most at risk. Healthcare providers who use the kit in medical procedures may also be affected.
Check for model number K-204 on the kit. Affected units were sold with batch codes 01K through 9ZK (e.g., 01K, 02K, ..., 99K, 9XK, 9YK, 9ZK).
Inspect the packaging for partial heat seals that may indicate inadequate sterility.
The recall states that a small percentage of units have inadequate seals, so not all kits are safe. Only affected units should be checked.
Check for model number K-204 and batch codes 01K through 9ZK (e.g., 01K, 02K, ..., 99K, 9XK, 9YK, 9ZK).
The recall does not specify a remedy, so check the packaging for partial seals and contact Olympus if unsure.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0973-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0973-2021 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.
