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
- EOQ — Bronchoscope (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.