Recall Z-0059-2026
Olympus Corporation of the Americas · initiated September 11, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Codes / lots: Model No. BF-PE2; UDI: 4953170339974; All Serial No.
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0059-2026
- Initiated
- September 11, 2025
- Posted by FDA
- October 16, 2025
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Quantity
- 2 units US; 4,289 units OUS
- Distribution
- US Nationwide Distribution.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0045-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0046-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0047-2026 Class I | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0048-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0049-2026 Class I | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0050-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0051-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0052-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF-H1100Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0053-2026 Class I | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0054-2026 Class I | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0055-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0056-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0057-2026 Class I | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0058-2026 Class I | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0060-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF-Q170Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0061-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0062-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-ACAdditional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0063-2026 Class I | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0064-2026 Class I | BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0065-2026 Class I | EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0066-2026 Class I | EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |
| Z-0067-2026 Class I | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | 09/11/2025Open, Classified |