Olympus Corporation of the Americas Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
All serial numbers BF-XT40** OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 UDI: 04953170055980 BF-P60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 UDI: 04953170339288 BF-MP60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 UDI: 04953170338394 BF-1T60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 UDI: 04953170339264
Olympus Corporation of the Americas is recalling Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60 due to There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Recommended Action
Per FDA guidance
An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 6/8/23 was sent to customers. Actions to be taken by the company: The labelling will be updated to include specificity about laser compatibility, improved instructions regarding patient preparation, and warnings about patient injury and death resulting from incompatible laser use. Actions to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names. 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 compatible laser type. 3. Ensure all personnel are completely knowledgeable and thoroughly aware that Olympus laser compatible bronchoscopes are compatible only with Nd: YAG laser or 810 nm diode lasers. 4. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0427 5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Olympus requests that you report complaints, including any injuries associated with laser procedures with Olympus bronchoscopes, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Olympus regrets any inconvenience caused and fully appreciates your cooperation in this matter. Please do not hesitate to call (647) 999-3203 or email: at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
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