FDA Device Recalls

Recalls /

#211983

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.

FDA product code
EOQBronchoscope (Flexible Or Rigid)
Device class
Class 2
Medical specialty
Ear, Nose, Throat
510(k) numbers
K060243
Affected lot / code info
1. Model Number: K-201; UDI-DI: 04953170245466; All Lots. 2. Model Number: K-202; UDI-DI: 04953170245480; All Lots 3. Model Number: K-203; UDI-DI: 04953170245503; All Lots 4. Model Number: K-204; UDI-DI: 04953170245527; All Lots

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm
Olympus Corporation of the Americas
Address
3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern
US nationwide distribution.

Timeline

Recall initiated
2025-01-15
Posted by FDA
2025-02-11
Status

Source: openFDA Device Recall endpoint. Recall record ID #211983. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.