Olympus Corporation of the Americas: Medical Device Recall in 2021 - (Recall #: Z-2497-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 17, 2021

Date Posted: September 29, 2021

Recall Number: Z-2497-2021

Event ID: 88560

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.

Status: Terminated

Product Quantity: 27 globally (21 US)

Code Information:

1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060

Distribution Pattern:

US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.

Voluntary or Mandated:

Voluntary: Firm initiated