Regulatory Record: Windstone Medical Packaging, Inc.

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Windstone Medical Packaging, 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.

Enforcement history

On 2026-04-29, Argus HQ recorded a FDA recall for Windstone Medical Packaging, Inc., rated "high" severity in Argus HQ's classification: Windstone Medical Packaging, Inc. — Class II recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 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 Windstone Medical Packaging, Inc., rated "high" severity in Argus HQ's classification: Windstone Medical Packaging, Inc. — Class II recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 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 Windstone Medical Packaging, Inc., rated "high" severity in Argus HQ's classification: Windstone Medical Packaging, Inc. — Class II recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A 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 Windstone Medical Packaging, Inc., rated "critical" severity in Argus HQ's classification: Windstone Medical Packaging, Inc. — Class I recall: Custom Convenience Kit containing recalled Medline Namic Angiographic Control Sy… 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 Windstone Medical Packaging, Inc., rated "high" severity in Argus HQ's classification: Windstone Medical Packaging, Inc. — Class II recall: Aligned Medical AMS16835 Fluids Kit RX An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Windstone Medical Packaging, Inc. has 5 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).

Frequently asked questions

How many FDA actions does Argus HQ track for Windstone Medical Packaging, Inc.?

21 total: 0 warning letters, 21 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Windstone Medical Packaging, Inc.?

August 5, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Windstone Medical Packaging, Inc. had product recalls?

Yes, 21 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Windstone Medical Packaging, Inc. 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.

Related enforcement actions

• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray -… →
• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminec… →
• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pac… →
• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve B… →
• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath T… →
• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack -… →
• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT,… →
• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray -… →
• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred… →
• Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pac… →

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