Class II recall Z-3305-2026: Merit Medical Systems, Inc.
Class II recall Z-3305-2026: Merit Medical Systems, Inc. (Utah): Merit Medical Systems, Inc. Dated 28 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 10 related UT FDAPulse records and the 5-column CSV export.
| 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 |
| Peer records CSV (11 UT records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Class II recall Z-3305-2026: Merit Medical Systems, Inc. and 11 Utah peers
- Utah FDAPulse records like this one: 11
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Utah peer: $2,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.
What is the FDAPulse record for Class II recall Z-3305-2026: Merit Medical Systems, Inc. in Utah?
Class II device recall Z-3305-2026 by Merit Medical Systems, Inc.: Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have
How does Class II recall Z-3305-2026: Merit Medical Systems, Inc. compare to other Utah FDAPulse records?
It is 28 days old, still within a typical 45-day follow-up window.
Class II recall Z-3305-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3305-2026 | UT | 2026-10-07 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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