Olympus K-203 Guide Sheath Kit 2.6MM: Risk of infection from poor seal

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Recalling firmAomori Olympus Co., Ltd.2 Chome 248-1, Okkonoki · Kuroishi, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling K-203 Guide Sheath Kits 2.6MM due to a small percentage of sterile packages having poor seals. This could lead to infections if non-sterile equipment is used during medical procedures.

Why it’s dangerous

The kits have a partial heat seal in some sterile packages, which means the packaging might not be airtight. If the equipment isn't sterile, it could introduce infections during medical procedures.

Who’s affected

Healthcare professionals using the K-203 Guide Sheath Kit with endoscopes for tissue sampling. Patients at risk if the kit is used without proper sterility.

How to tell if you have this one

Check for the model number K-203 on the kit. These kits were sold with endoscopes for collecting respiratory tissue samples.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Package Seal
Inspect the packaging for a partial heat seal; if the seal is broken or missing, do not use the kit.

✎ GovInfoNow

Questions people ask

Is this kit safe to use?

The recall states that a small percentage of kits have inadequate seals, so they may not be sterile. Use only kits with confirmed proper seals.

How can I tell if I have the recalled kit?

Look for the model number K-203 on the kit, which is used with endoscopes for respiratory tissue sampling.

What should I do if I have the kit?

Inspect the packaging for a partial heat seal. If the seal is broken or missing, do not use the kit.

Take action

Contact Olympus

We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1052-2021 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1052-2021 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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Where this comes from

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.

Official source: FDA Recall #Z-1052-2021 (January 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1052-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Aomori Olympus Co., Ltd. recalls K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue

Lower-risk recall