Drug recall
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use…
FDA recall event 96087 · Class I · Olympus Corporation of the Americas
Key facts
| Event ID | 96087 |
|---|---|
| Recall numbers | Z-1071-2025 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient. |
| Initiation date | Jan 15, 2025 |
| Report date | Feb 19, 2025 |
| 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: