Reported Feb 19, 2025 · Ongoing
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide…
Olympus Corporation of the Americas
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
K-201 | Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush |
K-202 | Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps |
K-203 | Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush |
K-204. | Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Used to collect cells or tissue specimens in the respiratory organs. |
- Amount recalled
- 454 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Using this product could cause serious injury, illness or death — stop using it now.
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