Z-0063-2026Class I
Evis Exera III Bronchovideoscope Olympus Bf-Q190
OLYMPUS Corporation of the Americas / initiated 2025-09-11 / Open, Classified / root cause: design
Olympus Corporation of the Americas began a recall of EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 on . FDA classified it as Class I and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0063-2026
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- OLYMPUS Corporation of the Americas
- Product
- Evis Exera III Bronchovideoscope Olympus Bf-Q190
- Product code
- EOQ Bronchoscope (Flexible Or Rigid)
- 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.
- Root cause tag
- design
- FDA 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 at 647-999-3203 or by email at [email protected].
- Quantity in commerce
- 916 units US; 1,402 units OUS
- Distribution
- US Nationwide Distribution.
- Product codes and lots
- Model No. BF-Q190; UDI: 4953170434792, 4953170335198; All Serial No.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0045-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0046-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0047-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0048-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0049-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0050-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0051-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0052-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0053-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0054-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0055-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0056-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0057-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0058-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0059-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0060-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0061-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0062-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0063-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0064-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0065-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0066-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0067-2026 | Class I | Ongoing | Voluntary: Firm initiated |
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