Drug recall
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel…
FDA recall event 91840 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 91840 |
|---|---|
| Recall numbers | Z-1418-2023 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There have been complaints that the clip did not come out of the tube sheath during the procedure. |
| Initiation date | Feb 23, 2023 |
| Report date | Apr 26, 2023 |
| 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: