HIGH
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
STAQ Pharma
Labeling: Incorrect
HIGH
Olympus Bronchofiberscope Recalled Due to Safety Concerns
Olympus Corporation of the Americas recalled 1,007 bronchofiberscopes on September 11, 2025, due to safety concerns related to their use with laser and high-frequency therapy equipment. The recall affects devices distributed nationwide in the U.S. and involves additional instructions for safe use.
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 OES Bronchofiberscope Olympus BF Type P60, Model No. BF-P60. A total of 1,007 units are recalled in the U.S., with an additional 5,443 units affected worldwide. The devices were distributed nationwide.
The Hazard
The recall addresses safety concerns when using bronchoscopes in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. The updates clarify instructions for effective and safe use.
Reported Incidents
No specific incidents or injuries have been reported related to this recall. The recall is classified as Class I, indicating a high hazard level.
What to Do
Stop using the device immediately. Healthcare providers and patients should follow the manufacturer's recall instructions. Contact Olympus Corporation of the Americas for further guidance.
Contact Information
For more information, contact Olympus Corporation of the Americas. Visit their website or call for additional assistance.
Key Facts
- Recall date: September 11, 2025
- Quantity recalled: 1,007 units in the U.S.
- Classification: Class I hazard
- 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 TypeBronchofiberscope
Sold At
Multiple Retailers
Product Details
Categories
Model Numbers
Model No. BF-P60
UDI: 4953170339196
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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