Z-2497-2021Class II

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

Name: Z-2497-2021 EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Creator: Olympus Corporation of the Americas
Published: 2021-08-17
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-08-17 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 on 2021-08-17. FDA classified it as Class II and gives the reason as "A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2497-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-17
Posted: 2021-09-21
Terminated: 2024-01-12
Recalling firm: OLYMPUS Corporation of the Americas
Product: EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On August 17, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Olympus will repair your unit free of charge. An Olympus representative will contact you to make arrangements for return of your affected bronchoscope. If you have further questions about this recall, please contact [email protected] for additional information.
Quantity in commerce: 27 globally (21 US)
Distribution: US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.
Product codes and lots: 1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2497-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2497-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-21

Product code EOQ

K023984Class IIModification to Olympus Bronchoscopes Bf-40 Series, Bf-240 Series, and Bf-160 SeriesThe Olympus Optical Co. / cleared 2003-01-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)