Olympus recalls single-use guide sheath kits (K-201 to K-204) due to potential radiopaque tip disassociation and falling off during use, which could lead to patient injury.
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Olympus is recalling single-use guide sheath kits (K-201 to K-204) because the radiopaque tip might detach and fall into the patient during procedures. This poses a risk of injury if the tip enters the patient's body.
The radiopaque tip of the guide sheath component may detach and fall off during use, potentially entering the patient's body. This could cause injury if the tip is not properly secured and remains in the patient's respiratory tract.
Healthcare professionals using these kits for respiratory tissue sampling are most at risk. Patients undergoing procedures with these kits could be injured if the radiopaque tip falls into their body.
Check for model numbers K-201, K-202, K-203, or K-204 on the kits. These kits are sold for respiratory tissue sampling and were manufactured with specific lot numbers.
Look for model numbers K-201, K-202, K-203, or K-204 on the kit packaging or label.
Reach out to Olympus Corporation of the Americas for specific instructions on how to handle the recalled kits.
The radiopaque tip of the guide sheath component may detach and fall off during use, potentially entering the patient's body and causing injury.
Model numbers K-201, K-202, K-203, and K-204 are affected.
Check the model number on the kit; affected kits have model numbers K-201, K-202, K-203, or K-204.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1071-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1071-2025 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.
