# Class II recall Z-3247-2026: Olympus Corporation of the Americas

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

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3247-2026 |
| Recalling firm | Olympus Corporation of the Americas |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. |
| Reason | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| Quantity | 816 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU. |
| Recall initiated | 2026-08-19 |
| Reported | 2026-09-30 |
| 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 36 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-3247-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.