Has Windstone Medical Packaging, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 22 total FDA actions tied to Windstone Medical Packaging, Inc.: 0 warning letters, 22 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-09-16; Argus observed and indexed it on 2026-09-23.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Windstone Medical Packaging, Inc. — Class II recall: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B

Name: FDA Recall Record — Windstone Medical Packaging, Inc.
Creator: Argus HQ
Published: 2026-09-16
License: https://argushq.ai/methodology

Event date: 2026-09-16 00:00:00Z
Observed: 2026-09-23 04:20:24Z
Source ID: Z-3138-2026
Payload hash: 14ffd0f8ac2cc9f071882642…

Summary

The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation. Status: Ongoing.

Entities

Windstone Medical Packaging, Inc.

View source record ↗

Frequently asked questions

Has Windstone Medical Packaging, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 22 total FDA actions tied to Windstone Medical Packaging, Inc.: 0 warning letters, 22 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-09-16; Argus observed and indexed it on 2026-09-23.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Windstone Medical Packaging, Inc. — Class II recall: AMS Convenience Kit:  DSAEK Pack - RX, Part Number AMS12394B. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-3138-2026

MLA

"Windstone Medical Packaging, Inc. — Class II recall: AMS Convenience Kit:  DSAEK Pack - RX, Part Number AMS12394B." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-3138-2026.

Chicago

Argus HQ Research. "Windstone Medical Packaging, Inc. — Class II recall: AMS Convenience Kit:  DSAEK Pack - RX, Part Number AMS12394B." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-3138-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_windstone_medical_packaging_inc_z_3138_2026_2026,
  title = {Windstone Medical Packaging, Inc. — Class II recall: AMS Convenience Kit:  DSAEK Pack - RX, Part Number AMS12394B},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-3138-2026},
  note = {Accessed: September 23, 2026}
}

Informational only. Not legal, financial, or medical advice.