Drug recall
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare…
FDA recall event 97733 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 97733 |
|---|---|
| Recall numbers | Z-0482-2026, Z-0483-2026 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to…, Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton. |
| Initiation date | Oct 6, 2025 |
| Report date | Nov 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: