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Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
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HIGH
Olympus Recalls Bronchoscopes Due to Safety Concerns
Olympus Corporation recalled 1,070 EVIS EXERA II bronchoscopes on September 11, 2025. The recall addresses safety concerns regarding their use with laser and high-frequency therapy equipment. Healthcare providers should stop using these devices immediately.
Quick Facts at a Glance
- Recall Date
- September 11, 2025
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions
Product Details
The recall involves the EVIS EXERA II Bronchovideoscope Olympus BF Type P180. A total of 1,070 units are recalled in the U.S. and 2,180 units internationally. The devices were distributed nationwide.
The Hazard
The recall stems from additional instructions for use updates. These updates clarify the safe and effective use of bronchoscopes when combined with laser, argon plasma coagulation, and high-frequency therapy equipment.
Reported Incidents
No specific incidents, injuries, or deaths have been reported in connection with this recall. However, the risk associated with improper use necessitates immediate action.
What to Do
Stop using the affected bronchoscopes immediately. Patients and healthcare providers should follow the recall instructions provided by Olympus Corporation.
Contact Information
For further instructions, contact Olympus Corporation of the Americas. Visit their website or call customer service for assistance.
Key Facts
- Recall date: September 11, 2025
- Quantity: 1,070 units in the U.S.
- Classification: Class I
- High hazard level
- Immediate action required
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeBronchoscopes
Sold At
Multiple Retailers
Product Details
Categories
Model Numbers
Model No. BF-P180
UDI: 4953170339288
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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