FDA Reports Ongoing Recall of Windstone Medical Packaging Convenience Kits
An ongoing FDA Class II recall covers 100 medical convenience kits containing recalled lidocaine.
4 reports on this incident · first at Aug 20, 2026, 8:11 a.m. ET
Earlier reports
Aug 20, 2026, 8:23 a.m. ET
FDA Assigns Class II Hazard Rating to Medical Kit Recall
On August 5, 2026, the Food and Drug Administration classified the ongoing recall of medical convenience kits from Billings-based Windstone Medical Packaging, Inc. as a Class II hazard under recall number Z-2817-2026. The FDA defines Class II as its middle risk category, applied where exposure to a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote.
Windstone Medical Packaging initially launched the recall on June 17, 2026, for 100 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as Block Tray - RX, Part Number AMS12414. The affected items carry Lot Numbers: 230411 and UDI/DI B098AMS124140. The recall was issued because the kits contain Elevaris Lidocaine HCl injection USP, which Elevaris Medical Devices Inc. recalled due to supplier quality issues.
The ongoing recall covers nationwide distribution in AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, and WA. FDA database records list no other enforcement actions for Windstone Medical Packaging, Inc.
Aug 20, 2026, 8:14 a.m. ET
FDA Closes Recall of Medical Convenience Kits Containing Recalled Lidocaine
The Food and Drug Administration (FDA) has closed the recall action for medical convenience kits packaged by Windstone Medical Packaging, Inc., according to an FDA enforcement report dated August 5, 2026. Closing the action indicates that the agency considers the recall carried out. The affected kits carry UDI/DI B098AMS124140 and Lot Numbers: 230411.
The recall, listed under recall number Z-2817-2026, involved 100 kits of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as Block Tray - RX, Part Number AMS12414. The action was initiated on June 17, 2026. Billings-based Windstone Medical Packaging issued the recall because the kits contained Elevaris Lidocaine HCl injection USP, which was recalled by Elevaris Medical Devices Inc. due to supplier quality issues.
FDA enforcement records show nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, and WA. The FDA classified the event as Class II, defined by agency guidelines as a situation where product exposure may cause temporary or medically reversible health consequences, or where the risk of serious health consequences is remote. The FDA database records no other enforcement actions for Windstone Medical Packaging, Inc.
Aug 20, 2026, 8:11 a.m. ETFirst report
Windstone Medical Packaging Recalls Convenience Kits Containing Recalled Lidocaine
On August 5, 2026, an official FDA enforcement report published details of an ongoing recall initiated on June 17, 2026, by Windstone Medical Packaging, Inc., based in Billings. The action, classified under recall number Z-2817-2026, covers 100 kits of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414.
The recalled products carry UDI/DI B098AMS124140 and Lot Number 230411. According to the FDA enforcement report, Windstone Medical Packaging issued the recall because the convenience kits contain Elevaris Lidocaine HCl injection USP, which was recalled by Elevaris Medical Devices Inc. due to supplier quality issues. The FDA designated the event as a Class II recall, which agency guidelines define as a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recall status remains ongoing. Distribution was nationwide across 22 states: AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, and WA. FDA database records show no other enforcement action for Windstone Medical Packaging, Inc.
Was this report accurate and useful?
Sources
Revision history
- Version 120 Aug 2026, 12:42current
First published.
- Version 120 Aug 2026, 12:11current
First published.
- Version 120 Aug 2026, 12:23current
First published.
- Version 120 Aug 2026, 12:14current
First published.
How we work
This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.
Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.
Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.
None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.