Olympus Corporation of the Americas: Medical Device Recall in 2020 - (Recall #: Z-0119-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).

Product Classification:

Class II

Date Initiated: August 31, 2020

Date Posted: October 28, 2020

Recall Number: Z-0119-2021

Event ID: 86367

Reason for Recall:

The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures.

Status: Terminated

Product Quantity: 193 devices distributed in the U.S. 548 devices distributed globally.

Code Information:

All lot codes..

Distribution Pattern:

US Nationwide Distribution in states of: AK, AZ, CA, FL, GA, IL, LA, MA, ME, MI, MN, MS, NC, NM, NJ, NY, OR, SC, TN, WA, and WI; and International to: Japan.

Voluntary or Mandated:

Voluntary: Firm initiated