# Class II recall Z-3300-2026: Olympus Corporation of the Americas

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3300-2026 |
| Recalling firm | Olympus Corporation of the Americas |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A. |
| Reason | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. |
| Quantity | 50 units |
| Distribution | International distribution to the country of Japan. |
| Recall initiated | 2026-08-24 |
| Reported | 2026-10-07 |
| Firm location | Center Valley, PA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3300-2026%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.