How many FDA actions does Argus HQ track for ARROW INTERNATIONAL, LLC?

47 total: 0 warning letters, 47 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for ARROW INTERNATIONAL, LLC?

June 24, 2026. Argus HQ ingests new FDA enforcement records daily.

Has ARROW INTERNATIONAL, LLC had product recalls?

Yes, 47 recalls on file. See the full history below for each one.

Is this FDA enforcement data for ARROW INTERNATIONAL, 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.

Regulatory Record: ARROW INTERNATIONAL, LLC

FDA action counts

Total FDA actions	47
Warning letters	0
Recalls	47
Approval records	0
Form 483 inspection citations	0
Most recent action	June 24, 2026

Key takeaway: Argus HQ has recorded 47 FDA events for ARROW INTERNATIONAL, LLC: 0 warning letters, 47 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-04-29 to 2026-06-24. The most severe rating Argus HQ has assigned across this history is "critical". 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 2026-04-29, Argus HQ recorded a FDA recall for ARROW INTERNATIONAL, LLC, rated "high" severity in Argus HQ's classification: ARROW INTERNATIONAL, LLC — Class II recall: MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for ARROW INTERNATIONAL, LLC, rated "high" severity in Argus HQ's classification: ARROW INTERNATIONAL, LLC — Class II recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS C… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for ARROW INTERNATIONAL, LLC, rated "high" severity in Argus HQ's classification: ARROW INTERNATIONAL, LLC — Class II recall: FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHET… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for ARROW INTERNATIONAL, LLC, rated "high" severity in Argus HQ's classification: ARROW INTERNATIONAL, LLC — Class II recall: PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for ARROW INTERNATIONAL, LLC, rated "high" severity in Argus HQ's classification: ARROW INTERNATIONAL, LLC — Class II recall: Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for ARROW INTERNATIONAL, LLC, rated "high" severity in Argus HQ's classification: ARROW INTERNATIONAL, LLC — Class II recall: ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)1080… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for ARROW INTERNATIONAL, LLC, rated "high" severity in Argus HQ's classification: ARROW INTERNATIONAL, LLC — Class II recall: Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022203… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for ARROW INTERNATIONAL, LLC, rated "high" severity in Argus HQ's classification: ARROW INTERNATIONAL, LLC — Class II recall: Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 F… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-20, Argus HQ recorded a FDA recall for ARROW INTERNATIONAL, LLC, rated "critical" severity in Argus HQ's classification: ARROW INTERNATIONAL, LLC — Class I recall: Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-V… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-20, Argus HQ recorded a FDA recall for.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. ARROW INTERNATIONAL, LLC has 47 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 ARROW INTERNATIONAL, LLC?: 47 total: 0 warning letters, 47 recalls, 0 approval records, and 0 Form 483 inspection citations.
What is the most recent FDA action on file for ARROW INTERNATIONAL, LLC?: June 24, 2026. Argus HQ ingests new FDA enforcement records daily.
Has ARROW INTERNATIONAL, LLC had product recalls?: Yes, 47 recalls on file. See the full history below for each one.
Is this FDA enforcement data for ARROW INTERNATIONAL, 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). Regulatory Record: ARROW INTERNATIONAL, LLC. Digital Empire LLC. Retrieved from https://argushq.ai/company/arrow-international-llc

MLA

"Regulatory Record: ARROW INTERNATIONAL, LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/arrow-international-llc.

Chicago

Argus HQ Research. "Regulatory Record: ARROW INTERNATIONAL, LLC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/arrow-international-llc.

BibTeX

@misc{argushq_argushq_ai_company_arrow_international_llc_2026,
  title = {Regulatory Record: ARROW INTERNATIONAL, LLC},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/arrow-international-llc},
  note = {Accessed: July 13, 2026}
}

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