Recall Z-1071-2025— Olympus Corporation of the Americas

Name: FDA recall Z-1071-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-15

Class I · Ongoing

Class I FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-01-15. It names one FDA 510(k) clearance: K060243. 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.. Reason: Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient..

Recalling firm: Olympus Corporation of the Americas
Classification: Class I
Status: Ongoing
Initiated: 2025-01-15
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K060243 — OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13Olympus Medical Systems Corporation·cleared 2006-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.