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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 Bronchovideoscope Recalled Over Safety Concerns
Olympus Corporation of the Americas recalled the BF-H1100 bronchovideoscope on September 11, 2025, due to safety concerns when used with certain medical equipment. The recall affects 1,867 units distributed outside the U.S. Patients and healthcare providers should 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 Olympus Bronchovideoscope, Model No. BF-H1100, with UDI 4953170424229. The recall affects 1,867 units distributed outside the U.S.
The Hazard
The recall addresses updates to the Instructions for Use (IFU) for the bronchovideoscope. The updates clarify safe and effective use when combined with laser, argon plasma coagulation, and high-frequency therapy equipment.
Reported Incidents
No incidents, injuries, or deaths have been reported related to this recall. The hazard level is classified as high.
What to Do
Patients and healthcare providers must stop using the bronchovideoscope immediately. Follow the recall instructions provided by Olympus Corporation of the Americas.
Contact Information
For further instructions, contact Olympus Corporation of the Americas. Visit their website or call their customer service for assistance.
Key Facts
- Recall date: September 11, 2025
- Hazard level: High
- Model: BF-H1100
- UDI: 4953170424229
- Units affected: 1,867 OUS
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeBronchovideoscope
Sold At
Multiple Retailers
Product Details
Categories
Model Numbers
Model No. BF-H1100
UDI: 4953170424229
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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