# FDA recall Z-0119-2021

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2020-08-31.

## Product

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).

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0119-2021
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-31
- **Report date:** 2020-10-28
- **Termination date:** 2022-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0119-2021

## Citation

> AI Analytics. FDA recall Z-0119-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0119-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*