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fda_recall · device_recall · high

Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray -…

Event date
2026-08-05 00:00:00Z
Observed
2026-08-12 04:20:22Z
Source ID
Z-2817-2026
Payload hash
95d90dc7fb5145ac54970cb4

Summary

Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues. Status: Ongoing.

Frequently asked questions

Has Windstone Medical Packaging, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 21 total FDA actions tied to Windstone Medical Packaging, Inc.: 0 warning letters, 21 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 2026-08-05; Argus observed and indexed it on 2026-08-12.
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 ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  Block Tray -…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-2817-2026
MLA
"Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  Block Tray -…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-2817-2026.
Chicago
Argus HQ Research. "Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  Block Tray -…." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-2817-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_windstone_medical_packaging_inc_z_2817_2026_2026,
  title = {Windstone Medical Packaging, Inc. — Class II recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  Block Tray -…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-windstone-medical-packaging-inc-z-2817-2026},
  note = {Accessed: August 13, 2026}
}

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