FDA action counts
| Total FDA actions | 4 |
|---|---|
| Warning letters | 0 |
| Recalls | 4 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | June 24, 2026 |
Enforcement history
On 2026-05-06, Argus HQ recorded a FDA recall for Merit Medical Systems, Inc., rated "high" severity in Argus HQ's classification: Merit Medical Systems, Inc. — Class II recall: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Merit Medical Systems, Inc., rated "high" severity in Argus HQ's classification: Merit Medical Systems, Inc. — Class II recall: Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Merit Medical Systems, Inc., rated "high" severity in Argus HQ's classification: Merit Medical Systems, Inc. — Class II recall: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-24, Argus HQ recorded a FDA recall for Merit Medical Systems, Inc., rated "high" severity in Argus HQ's classification: Merit Medical Systems, Inc. — Class II recall: Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 0088445052… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Merit Medical Systems, Inc. has 4 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Merit Medical Systems, Inc. has 4 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Frequently asked questions
- Does Argus HQ track new FDA actions for Merit Medical Systems, Inc. automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Merit Medical Systems, Inc. is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Merit Medical Systems, Inc.?
- 4 total: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Merit Medical Systems, Inc.?
- June 24, 2026. Argus HQ ingests new FDA enforcement records daily.
- Has Merit Medical Systems, Inc. had product recalls?
- Yes, 4 recalls on file. See the full history below for each one.
Every FDA action tied to this company, the week it happens.
Free weekly briefing. Real-time alerts on paid plans.
Related enforcement actions
- Merit Medical Systems, Inc. — Class II recall: Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 0088445052… →
- Merit Medical Systems, Inc. — Class II recall: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY →
- Merit Medical Systems, Inc. — Class II recall: Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY →
- Merit Medical Systems, Inc. — Class II recall: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY →
Compare with
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
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.
Argus HQ Research (2026). FDA Enforcement History: Merit Medical Systems, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/company/merit-medical-systems-inc
"FDA Enforcement History: Merit Medical Systems, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/merit-medical-systems-inc.
Argus HQ Research. "FDA Enforcement History: Merit Medical Systems, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/merit-medical-systems-inc.
@misc{argushq_argushq_ai_company_merit_medical_systems_inc_2026,
title = {FDA Enforcement History: Merit Medical Systems, Inc.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/merit-medical-systems-inc},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗