# Class II recall Z-3305-2026: Merit Medical Systems, Inc.

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

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3305-2026 |
| Recalling firm | Merit Medical Systems, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:   S420GH/EUA, S620GH/EUA;    Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB;    Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA |
| Reason | Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection. |
| Quantity | 104 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, GA and the countries of  France, Ireland, Canada, Switzerland. |
| Recall initiated | 2026-08-10 |
| Reported | 2026-10-07 |
| Firm location | South Jordan, UT, 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-3305-2026%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.