Z-2494-2023Class II

Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F

Name: Z-2494-2023 Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F
Creator: Olympus Corporation of the Americas
Published: 2023-07-27
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-07-27 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F on 2023-07-27. FDA classified it as Class II and gives the reason as "Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2494-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-27
Posted: 2023-08-31
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Product code: PSV Ultrasound Bronchoscope
Reason for recall: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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].
Quantity in commerce: 4115 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 04953170356360 and 04953170399831; All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2494-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2490-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2491-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2492-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2493-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2494-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2495-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2496-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2497-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2498-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2499-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2500-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2501-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2502-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2503-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31
Z-2504-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-31

Product code PSV

K070983Class IIOlympus Xbf-Uc180f-Dt8 Ultrasonic Bronchofibervideoscope Used with Aloka Ssd-Alpha 5/10 Ultrasound SystemOlympus Medical Systems Corporation / cleared 2007-07-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)