Recall Z-0065-2026 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
| Date | Oct 16, 2025 (initiated Sep 11, 2025) |
| Status | Open, Classified |
| Reason | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Root cause | Device Design |
| Action | An URGENT Medical Device Correction notification dated 9/11/25 was mailed to consignees to notify them of this recall action. Consignees are asked to carefully read the recall notification and identify any affected devices in their inventory. Consignees are to ensure all personnel are knowledgeable and aware of the updated IFU. Consignees are to acknowledge receipt of the recall notification through Olympus' web portal at https://olympusamerica.com/recall. Forward the provided recall notification if product was further distributed. Consignees with any questions can contact Cynthia Ow by phone |
| Quantity | 262 units US; 558 units OUS |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES The Olympus Optical Co., Jan 31, 2003 |