Baxter Healthcare Corporation — FDA Compliance Timeline

FDA action counts

Enforcement history

On 2026-07-08, Argus HQ recorded an FDA recall for Baxter Healthcare Corporation, rated "critical" severity in Argus HQ's classification: Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal…. On 2026-07-08, Argus HQ recorded an FDA recall for Baxter Healthcare Corporation, rated "critical" severity in Argus HQ's classification: Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog…. On 2026-07-08, Argus HQ recorded an FDA recall for Baxter Healthcare Corporation, rated "high" severity in Argus HQ's classification: Baxter Healthcare Corporation — Class II recall: Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjun…. On 2026-07-08, Argus HQ recorded an FDA recall for Baxter Healthcare Corporation, rated "critical" severity in Argus HQ's classification: Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Cat…. On 2026-07-08, Argus HQ recorded an FDA recall for Baxter Healthcare Corporation, rated "critical" severity in Argus HQ's classification: Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog…. On 2026-06-10, Argus HQ recorded an FDA recall for Baxter Healthcare Corporation, rated "high" severity in Argus HQ's classification: Baxter Healthcare Corporation — Class II recall: Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog N…. 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Baxter Healthcare Corporation has 6 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 Baxter Healthcare Corporation 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 Baxter Healthcare Corporation is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Baxter Healthcare Corporation?

209 total: 0 warning letters, 209 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Baxter Healthcare Corporation?

August 19, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Baxter Healthcare Corporation had product recalls?

Yes, 209 recalls on file. See the full history below for each one.

Related enforcement actions

• Baxter Healthcare Corporation — Class I recall: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; So… →
• Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog… →
• Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Cat… →
• Baxter Healthcare Corporation — Class II recall: Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjun… →
• Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog… →
• Baxter Healthcare Corporation — Class I recall: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal… →
• Baxter Healthcare Corporation — Class II recall: Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog N… →
• Baxter Healthcare Corporation — Class I recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937.… →
• Baxter Healthcare Corporation — Class II recall: Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS… →
• Baxter Healthcare Corporation — Class II recall: Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570… →

Compare with

• Baxter Healthcare Corporation vs Philips North America
• Baxter Healthcare Corporation vs Medline Industries, LP
• Baxter Healthcare Corporation vs Boston Scientific Corporation
• Baxter Healthcare Corporation vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
• Baxter Healthcare Corporation vs Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)