Key facts
| Recalling firm | Windstone Medical Packaging, Inc. |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19 |
| Classification | Class II |
| Recall number | Z-2819-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | 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. |
What consumers should do
Facilities, clinicians, and consumers holding an affected unit or lot of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19 should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Windstone Medical Packaging, Inc.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Windstone Medical Packaging, Inc. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Windstone Medical Packaging, Inc. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.
What this classification means
A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.
Windstone Medical Packaging, Inc.’s FDA history
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.
Frequently asked questions
- Who should I contact about this recall?
- Contact Windstone Medical Packaging, Inc. directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.
- Has Windstone Medical Packaging, Inc. had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 21 total FDA actions tied to Windstone Medical Packaging, Inc., including 21 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2819-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
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Related enforcement actions
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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.
Argus HQ Research (2026). FDA Class II Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled… by Windstone Medical Packaging, Inc.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/windstone-medical-packaging-z-2819-2026-2026-08-05
"FDA Class II Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled… by Windstone Medical Packaging, Inc.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/windstone-medical-packaging-z-2819-2026-2026-08-05.
Argus HQ Research. "FDA Class II Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled… by Windstone Medical Packaging, Inc.." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/recall/windstone-medical-packaging-z-2819-2026-2026-08-05.
@misc{argushq_argushq_ai_recall_windstone_medical_packaging_z_2819_2026_2026_08_05_2026,
title = {FDA Class II Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled… by Windstone Medical Packaging, Inc.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/windstone-medical-packaging-z-2819-2026-2026-08-05},
note = {Accessed: August 27, 2026}
}Source: FDA.gov — Recalls ↗