Olympus Bronchovideoscope, Models BF-3C160.
FDA Recall Z-2503-2023 · Posted 2023-08-31
Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2023-07-27
Product Quantity1004 units
Reason for Recall
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Firm Action
Consignees were mailed an Urgent Medical Device Correction notification dated 7/27/2023 via UPS. The notification asks that consignees inspect their inventory for recalled devices and check clinical areas to see if any remain in use. Consignees are to ensure that all personnel, including clinical staff, are completely knowledgeable of this recall notification and addendum, which instructs users to slide the endotracheal tube along the entire length of the tracheal intubation scope insertion section to confirm compatibility before using on a patient. Consignees are asked to complete and return the provided response form to Sedgwick via email at [email protected] or by fax at 866-552-4917. Any questions about the acknowledgement form may be directed by phone to 866-737-4762. If product has been further distributed, please forward the notification to those secondary consignees and maintain records of your documentation process. Consignees are to report any complaints to Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) and FDA Medwatch. Any further questions are to be directed to Tara Safi by email at [email protected].
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.