Olympus Single Use Guide Sheath Kits: Risk of Radiopaque Tip Falling Off
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.
Use caution until it’s fixed
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/53080-olympus-single-use-guide-sheath-kits-risk-of-radiopaque-tip.
Source Summary by GovInfoNow · govinfonow.com/recall/53080-olympus-single-use-guide-sheath-kits-risk-of-radiopaque-tip · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1071-2025
Cite this page
“Olympus Single Use Guide Sheath Kits: Risk of Radiopaque Tip Falling Off.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53080-olympus-single-use-guide-sheath-kits-risk-of-radiopaque-tip. Based on FDA recall #Z-1071-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1071-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Olympus- Category
Medical device
What to do — step by step
Check Kit Model Number
Look for model numbers K-201, K-202, K-203, or K-204 on the kit packaging or label.
Contact Olympus for Details
Reach out to Olympus Corporation of the Americas for specific instructions on how to handle the recalled kits.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1071-2025 (January 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1071-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.