Olympus Corporation of the Americas BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
All serial numbers
Products Sold
All serial numbers
Olympus Corporation of the Americas is recalling BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 due to The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Recommended Action
Per FDA guidance
On August __, 2021, the firm distributed Urgent Medical Device Corrective Action letters to customers. The applicable addenda to the reprocessing instructions were attached to the letters. Action steps to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides updated information or instructions on the chemicals to be used for reprocessing, the sterilization conditions, rinsing after high-level disinfection, and recommendation on using sterilization. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the new reprocessing steps. 4. Additional copies of the new Operation Manuals can be obtained by accessing our OlympusConnect site and downloading a copy of the new Manuals. Please visit our OlympusConnect customer website: at https://www.OlympusConnect.com New users will need to register. Once registered select [Product Support] on the left navigation bar, then select [Instruction Manuals], locate the applicable product codes and select the [Download] option. 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number and provide your contact information as indicated in the portal. 6. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. For further information, contact the firm's Technical Assistance Center at 1-800-848-9024, option 1.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026