Single Use Guide Sheath Kit (Olympus) – radiopaque tip risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Channe
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
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
Products Sold
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
Olympus Corporation of the Americas is recalling Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. due to Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026