Recall Z-1071-2025 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
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, Bio
| Date | Feb 11, 2025 (initiated Jan 15, 2025) |
| Status | Open, Classified |
| Reason | Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 454 units |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060243 | OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 Olympus Medical Systems Corporation, Jun 23, 2006 |