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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.
Labeling: Incorrect or Missing Lot and/or Exp Date
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HIGH
Olympus Recalls Bronchovideoscope Due to Safety Concerns
Olympus Corporation of the Americas recalled 3 bronchovideoscopes on September 11, 2025, due to safety clarification updates. The recall affects 1,987 units distributed outside the US. Healthcare providers must stop using the device immediately to ensure patient safety.
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 BF Type 1T150, with model number BF-1T150 and UDI 4953170308185. It is distributed nationwide in the US and internationally. The quantity recalled includes 3 units in the US and 1,987 units outside the US.
The Hazard
The recall addresses updates in the Instructions for Use (IFU) to clarify safe usage with laser, argon plasma coagulation, and high-frequency therapy equipment. The hazard level is classified as high due to the potential for improper use.
Reported Incidents
No specific incidents, injuries, or deaths have been reported related to this recall. The updates aim to prevent potential risks associated with improper use.
What to Do
Patients and healthcare providers should stop using the Olympus Bronchovideoscope BF Type 1T150 immediately. Follow the recall instructions provided by Olympus Corporation of the Americas.
Contact Information
For further instructions, contact Olympus Corporation of the Americas or your healthcare provider. Additional information can be found on the FDA website.
Key Facts
- 3 units recalled in the US
- 1,987 units recalled internationally
- High hazard level due to usage clarification
- Immediate action required for safety
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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-1T150
UDI: 4953170308185
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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