fda_recall · device_recall · critical

Windstone Medical Packaging, Inc. — Class I recall: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…

Event date
2026-07-08 00:00:00Z
Observed
2026-07-14 04:20:26Z
Source ID
Z-2619-2026
Payload hash
3d183c02535ff2de9cf2c1a3

Summary

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. Status: Ongoing.

Frequently asked questions

Has Windstone Medical Packaging, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 9 total FDA actions tied to Windstone Medical Packaging, Inc.: 0 warning letters, 9 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 critical severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.
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 I recall: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-2619-2026
MLA
"Windstone Medical Packaging, Inc. — Class I recall: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-2619-2026.
Chicago
Argus HQ Research. "Windstone Medical Packaging, Inc. — Class I recall: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-2619-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_windstone_medical_packaging_inc_z_2619_2026_2026,
  title = {Windstone Medical Packaging, Inc. — Class I recall: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-2619-2026},
  note = {Accessed: July 14, 2026}
}

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