How many FDA actions does Argus HQ track for Katalyst Surgical, LLC?

12 total: 0 warning letters, 12 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Katalyst Surgical, LLC?

May 13, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Katalyst Surgical, LLC had product recalls?

Yes, 12 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Katalyst Surgical, LLC official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

Katalyst Surgical, LLC — FDA Enforcement History

FDA action counts

Total FDA actions	12
Warning letters	0
Recalls	12
Approval records	0
Form 483 inspection citations	0
Most recent action	May 13, 2026

In short: Argus HQ has recorded 12 FDA events for Katalyst Surgical, LLC: 0 warning letters, 12 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-05-13 to 2026-05-13. The most severe rating Argus HQ has assigned across this history is "high". 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.

Enforcement history

On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC, rated "high" severity in Argus HQ's classification: Katalyst Surgical, LLC — Class II recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Nu… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC, rated "high" severity in Argus HQ's classification: Katalyst Surgical, LLC — Class II recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalo… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC, rated "high" severity in Argus HQ's classification: Katalyst Surgical, LLC — Class II recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC, rated "high" severity in Argus HQ's classification: Katalyst Surgical, LLC — Class II recall: DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalo… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC, rated "high" severity in Argus HQ's classification: Katalyst Surgical, LLC — Class II recall: DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog N… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC, rated "high" severity in Argus HQ's classification: Katalyst Surgical, LLC — Class II recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC, rated "high" severity in Argus HQ's classification: Katalyst Surgical, LLC — Class II recall: DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC, rated "high" severity in Argus HQ's classification: Katalyst Surgical, LLC — Class II recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Numb… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC, rated "high" severity in Argus HQ's classification: Katalyst Surgical, LLC — Class II recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Katalyst Surgical, LLC.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Katalyst Surgical, LLC has 12 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. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Frequently asked questions

How many FDA actions does Argus HQ track for Katalyst Surgical, LLC?: 12 total: 0 warning letters, 12 recalls, 0 approval records, and 0 Form 483 inspection citations.
What is the most recent FDA action on file for Katalyst Surgical, LLC?: May 13, 2026. Argus HQ ingests new FDA enforcement records daily.
Has Katalyst Surgical, LLC had product recalls?: Yes, 12 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Katalyst Surgical, LLC official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

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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). Katalyst Surgical, LLC — FDA Enforcement History. Digital Empire LLC. Retrieved from https://argushq.ai/company/katalyst-surgical-llc

MLA

"Katalyst Surgical, LLC — FDA Enforcement History." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/katalyst-surgical-llc.

Chicago

Argus HQ Research. "Katalyst Surgical, LLC — FDA Enforcement History." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/katalyst-surgical-llc.

BibTeX

@misc{argushq_argushq_ai_company_katalyst_surgical_llc_2026,
  title = {Katalyst Surgical, LLC — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/katalyst-surgical-llc},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗