Drug recall
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera…
FDA recall event 86367 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 86367 |
|---|---|
| Recall numbers | Z-0119-2021 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 31, 2020 |
| Report date | Oct 28, 2020 |
| Termination date | Dec 6, 2022 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: