Olympus Corporation Of The Americas recalls Olympus Single Use Guide Sheath Kits with the following product descriptions and model…

Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

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.

Olympus notified consignees on about 01/15/2024, via letter. Consignees were instructed to examine inventory and quarantine affected devices, cease usage of the product immediately, acknowledge receipt of the letter through the Olympus web portal, and to forward the notice to all applicable personnel and customers if further distributed.

• FDA enforcement recordOfficial FDA database entry for Z-1071-2025
• FDA 510(k) clearance · K060243The device's official FDA premarket clearance record
• FDA device classification · EOQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.4680The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.