—#216191

Product

BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K023984
Affected lot / code info: Model No. BF-TE2; UDI: 4953170339998; All Serial No.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 at 647-999-3203 or by email at Cynthia.Ow@olympus.com.

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: 2025-09-11
Posted by FDA: 2025-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216191. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.