Bronchovideoscope Reprocessing Instructions Updated for Sterilization Compliance
Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a high-risk medical device used in respiratory procedures. Improper reprocessing could lead to serious infections; although no illnesses or injuries have been reported, the hazard of infection from inadequate sterilization represents a risk-of-harm scenario requiring the issuance of validated updated procedures.
Plain-English summary
Olympus Corporation of the Americas is recalling the BF-XP160F EVIS EXERA Bronchovideoscope to issue validated, new reprocessing instructions. The updated procedures align with the FDA 2015 guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
The recall affects all serial numbers of the BF-XP160F model. A total of 644 units have been distributed domestically nationwide and internationally.
Healthcare facilities using this bronchovideoscope should implement the new reprocessing instructions provided by Olympus. Proper reprocessing of endoscopic equipment is critical to prevent cross-contamination and potential patient harm from inadequate sterilization.
The recalled product
- Product
- BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- improper-sterilization
- infection-risk
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