BF-P180 EVIS EXERA II Bronchovideoscope Reprocessing Instructions Validation Recall
Olympus Corporation issued updated reprocessing instructions for 1,177 BF-P180 EVIS EXERA II Bronchovideoscopes to ensure compliance with FDA validation standards for medical device sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 an FDA Class II recall with no reported illnesses or injuries. The recall involves issuing updated and validated reprocessing instructions to meet FDA 2015 guidance standards, classified as a preventive instruction correction.
Plain-English summary
Olympus Corporation of the Americas is recalling the BF-P180 EVIS EXERA II Bronchovideoscope to issue validated reprocessing instructions. The recall affects 1,177 units that have been distributed domestically nationwide and globally.
The firm is issuing new reprocessing instructions in accordance with FDA 2015 guidance on validating reprocessing methods and labeling for medical devices used in healthcare settings.
Healthcare facilities using this device should consult and implement the updated reprocessing instructions provided by Olympus Corporation.
The recalled product
- Product
- BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,177
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.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Same hazard · labeling correction
See all →- ModerateSurgical matrix patches recalled for labeling correction on wound dehiscence management
FDA (Devices) · 2025-09-17
- ModerateAbbott Amplatzer Steerable Delivery Sheath instructions for use updated
FDA (Devices) · 2022-04-13
- ModerateHeparin Activity Assay Labeling Correction: Reduced On-Board Stability
FDA (Devices) · 2021-10-27
Similar recalls
- HighBronchovideoscope Recall for Updated Sterilization and Reprocessing Instructions
FDA (Devices) · 2022-05-18
- CriticalBF-P180 bronchovideoscopes recalled for updated therapy equipment use instructions
FDA (Devices) · 2025-10-22
- HighBronchovideoscope Reprocessing Instructions Updated Due to Sterilization Concerns
FDA (Devices) · 2022-05-18
- CriticalBF-1T180 bronchovideoscopes recalled for clarified instructions on therapy equipment
FDA (Devices) · 2025-10-22
- HighBronchofibervideoscope Sterilization and Disinfection Procedure Update Recall
FDA (Devices) · 2022-05-18
- CriticalBF-1TQ180 bronchovideoscopes recalled for updated therapy equipment use instructions
FDA (Devices) · 2025-10-22