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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 EVIS EXERA III Bronchoscope Over Safety Concerns
Olympus Corporation recalled 4,297 EVIS EXERA III bronchoscopes on September 11, 2025. The recall follows updates to the instructions for use regarding safe operation with laser and high-frequency therapy equipment. Healthcare providers and patients must stop using the device 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 recalled product is the EVIS EXERA III Bronchoscope, Model No. BF-1TH190. It has a Unique Device Identifier (UDI) of 4953170434778. The devices were distributed across the United States.
The Hazard
The recall addresses additional instructions for safe and effective use of bronchoscopes in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. Improper use may lead to significant safety risks.
Reported Incidents
No specific incidents or injuries have been reported in connection with this recall. The classification is Class I, indicating a high level of hazard.
What to Do
Stop using the bronchoscope immediately. Follow the recall instructions provided by Olympus Corporation and consult your healthcare provider for further guidance.
Contact Information
For more information, contact Olympus Corporation of the Americas. Visit the FDA's recall page or call your healthcare provider.
Key Facts
- 4,297 units recalled in the US
- High hazard classification
- Immediate stop-use action required
- Contact Olympus for further instructions
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeBronchoscope
Sold At
Multiple Retailers
Product Details
Categories
Model Numbers
Model No. BF-1TH190
UDI: 4953170434778
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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