Olympus recalls K-202 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-202 Guide Sheath Kits that may have poor sterile packaging seals. Using these kits could lead to infections if non-sterile equipment is used during medical procedures.
The kits may have inadequate sterile packaging seals due to partial heat sealing. This could allow contaminants to enter the sterile equipment, increasing infection risk during medical procedures.
Medical professionals using endoscopes to collect respiratory tissue samples are most at risk. Patients receiving procedures with these kits could face infections.
Check for model number K-202 on the kit. The kits were sold with endoscopes for respiratory tissue sampling in the US from 2010 to 2020.
Inspect the packaging for signs of partial heat sealing, which may indicate inadequate sterility.
The recall does not specify that the kits are unsafe to use; however, they may have inadequate seals that could lead to infections.
Check for model number K-202 on the kit. The kits were sold with endoscopes for respiratory tissue sampling in the US from 2010 to 2020.
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-1051-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1051-2021 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.
