Regulatory Record: Medtronic Xomed, Inc.

FDA action counts

Enforcement history

On 2025-09-03, Argus HQ recorded an FDA recall for Medtronic Xomed, Inc., rated "high" severity in Argus HQ's classification: Medtronic Xomed, Inc. — Class II recall: IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. Th…. On 2025-04-30, Argus HQ recorded an FDA recall for Medtronic Xomed, Inc., rated "high" severity in Argus HQ's classification: Medtronic Xomed, Inc. — Class II recall: NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;…. On 2024-09-18, Argus HQ recorded an FDA recall for Medtronic Xomed, Inc., rated "high" severity in Argus HQ's classification: Medtronic Xomed, Inc. — Class II recall: Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069. On 2024-07-31, Argus HQ recorded an FDA recall for Medtronic Xomed, Inc., rated "critical" severity in Argus HQ's classification: Medtronic Xomed, Inc. — Class I recall: NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vi…. On 2024-01-17, Argus HQ recorded an FDA recall for Medtronic Xomed, Inc., rated "high" severity in Argus HQ's classification: Medtronic Xomed, Inc. — Class II recall: NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822970…. 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 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 ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Medtronic Xomed, Inc. has 5 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. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

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

How many FDA actions does Argus HQ track for Medtronic Xomed, Inc.?

5 total: 0 warning letters, 5 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Medtronic Xomed, Inc.?

September 3, 2025. Argus HQ ingests new FDA enforcement records daily.

Has Medtronic Xomed, Inc. had product recalls?

Yes, 5 recalls on file. See the full history below for each one.

Related enforcement actions

• Medtronic Xomed, Inc. — Class II recall: IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. Th… →
• Medtronic Xomed, Inc. — Class II recall: NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;… →
• Medtronic Xomed, Inc. — Class II recall: Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 →
• Medtronic Xomed, Inc. — Class I recall: NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vi… →
• Medtronic Xomed, Inc. — Class II recall: NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822970… →

Compare with

• Medtronic Xomed, Inc. vs Philips North America
• Medtronic Xomed, Inc. vs Boston Scientific Corporation
• Medtronic Xomed, Inc. vs Medline Industries, LP
• Medtronic Xomed, Inc. vs Baxter Healthcare Corporation
• Medtronic Xomed, Inc. vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.