Covidien LLC — FDA Compliance Timeline

FDA action counts

Enforcement history

On 2026-06-10, Argus HQ recorded a FDA recall for Covidien LLC, rated "high" severity in Argus HQ's classification: Covidien LLC — Class II recall: COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI cod… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-10, Argus HQ recorded a FDA recall for Covidien LLC, rated "high" severity in Argus HQ's classification: Covidien LLC — Class II recall: Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-10, Argus HQ recorded a FDA recall for Covidien LLC, rated "high" severity in Argus HQ's classification: Covidien LLC — Class II recall: Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF:… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-10, Argus HQ recorded a FDA recall for Covidien LLC, rated "high" severity in Argus HQ's classification: Covidien LLC — Class II recall: Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Covidien LLC 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. Covidien LLC 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. 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

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

How many FDA actions does Argus HQ track for Covidien LLC?

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 Covidien LLC?

June 10, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Covidien LLC had product recalls?

Yes, 4 recalls on file. See the full history below for each one.

Related enforcement actions

• Covidien LLC — Class II recall: Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF:… →
• Covidien LLC — Class II recall: Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 →
• Covidien LLC — Class II recall: COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI cod… →
• Covidien LLC — Class II recall: Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 →

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