Cook Incorporated — FDA Compliance Timeline

FDA action counts

Enforcement history

On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-1… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IM… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Re… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Or… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part N… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Cook Incorporated, rated "high" severity in Argus HQ's classification: Cook Incorporated — Class II recall: COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDL… An FDA.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Cook Incorporated has 21 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

Is this FDA enforcement data for Cook Incorporated 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.

How many FDA actions has Cook Incorporated had?

Argus HQ has recorded 21 FDA events for Cook Incorporated: 0 warning letters, 21 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Cook Incorporated?

The most recent FDA event Argus HQ has on file for Cook Incorporated is dated 2026-05-13, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Cook Incorporated 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 Cook Incorporated is observed, this page's event count and history update automatically.

Related enforcement actions

• Cook Incorporated — Class I recall: Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G473… →
• Cook Incorporated — Class I recall: Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G312… →
• Cook Incorporated — Class I recall: Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Cath… →
• Cook Incorporated — Class II recall: COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Numbe… →
• Cook Incorporated — Class II recall: COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-19… →
• Cook Incorporated — Class II recall: COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.… →
• Cook Incorporated — Class II recall: COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Refer… →
• Cook Incorporated — Class II recall: COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Refe… →
• Cook Incorporated — Class II recall: COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Numb… →
• Cook Incorporated — Class II recall: COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EX… →

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