Olympus BF-N20 Bronchofiberscope Reprocessing Instructions Updated for Compliance
Olympus is updating reprocessing instructions for the BF-N20 Bronchofiberscope to comply with FDA 2015 guidance on medical device reprocessing validation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II labeling and instruction update with no reported illnesses, injuries, or hospitalizations. The recall represents a precautionary update to comply with FDA 2015 guidance on device reprocessing validation.
Plain-English summary
Olympus Corporation of the Americas is issuing updated reprocessing instructions for the BF-N20 Bronchofiberscope, affecting 377 units distributed domestically nationwide and globally.
The new reprocessing instructions are validated in accordance with the FDA 2015 guidance on reprocessing medical devices in healthcare settings. Healthcare facilities using these devices should implement the updated reprocessing procedures provided by Olympus.
The recalled product
- Product
- BF-N20 OES Bronchofiberscope, Model No. BF-N20
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- labeling-defect
- sterilization-procedure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03