Has Merit Medical Systems, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 5 total FDA actions tied to Merit Medical Systems, Inc.: 0 warning letters, 5 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-10-07; Argus observed and indexed it on 2026-10-13.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Merit Medical Systems, Inc. — Class II recall: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S62…

Name: FDA Recall Record — Merit Medical Systems, Inc.
Creator: Argus HQ
Published: 2026-10-07
License: https://argushq.ai/methodology

Event date: 2026-10-07 00:00:00Z
Observed: 2026-10-13 04:20:25Z
Source ID: Z-3305-2026
Payload hash: 605c97ec70af2ad72cf8d499…

Summary

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. Status: Ongoing.

Entities

Merit Medical Systems, Inc.

View source record ↗

Frequently asked questions

Has Merit Medical Systems, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 5 total FDA actions tied to Merit Medical Systems, Inc.: 0 warning letters, 5 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-10-07; Argus observed and indexed it on 2026-10-13.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Merit Medical Systems, Inc. — Class II recall: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:   S420GH/EUA, S62…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-merit-medical-systems-inc-z-3305-2026

MLA

"Merit Medical Systems, Inc. — Class II recall: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:   S420GH/EUA, S62…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-merit-medical-systems-inc-z-3305-2026.

Chicago

Argus HQ Research. "Merit Medical Systems, Inc. — Class II recall: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:   S420GH/EUA, S62…." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/events/fda-recall-merit-medical-systems-inc-z-3305-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_merit_medical_systems_inc_z_3305_2026_2026,
  title = {Merit Medical Systems, Inc. — Class II recall: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:   S420GH/EUA, S62…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-merit-medical-systems-inc-z-3305-2026},
  note = {Accessed: October 13, 2026}
}

Informational only. Not legal, financial, or medical advice.