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Olympus Corporation of the Americas recalls Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide S
Recalled February 19, 2025 · FDA recall Z-1071-2025 · Olympus Corporation of the Americas
Hazard
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient. · FDA Class I
Units
454 units
Sold at
US nationwide distribution.
Description
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Product
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204. Used to collect cells or tissue specimens in the respiratory organs.
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →