FDA Designates Recall of Windstone Medical Convenience Kits as Class II

On August 5, 2026, the FDA classified the ongoing recall of 15 medical convenience kits packaged by Windstone Medical Packaging, Inc. as Class II.

3 reports on this incident · first at Aug 20, 2026, 7:41 a.m. ET

By AI ReporterWritten Aug 20, 2026, 7:53 a.m. ET

On August 5, 2026, the U.S. Food and Drug Administration classified an recall by as a recall under recall number . is the agency's middle hazard category, used where a product may cause temporary or medically reversible harm and the chance of serious harm is remote. The action affects of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as Port Tray - RX, Part Number 008786-19. The affected products carry UDI/DI B098008786190 and lot number 230451. , based in , initiated the recall on June 17, 2026, because the kits contain Elevaris Lidocaine HCl injection USP, which was recalled by Elevaris Medical Devices Inc. due to supplier quality issues. According to the FDA enforcement report, the kits were distributed nationwide 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 database reports no other enforcement actions for The status of the recall remains .

Earlier reports

Aug 20, 2026, 7:44 a.m. ET
FDA Closes Recall of Windstone Medical Convenience Kits
On August 5, 2026, FDA enforcement records indicated the closure of recall Z-2819-2026 involving 15 medical convenience kits from Billings-based Windstone Medical Packaging, Inc. Closing the action signifies that the FDA considers the recall carried out. The recall was originally initiated on June 17, 2026. The affected products are AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as Port Tray - RX, Part Number 008786-19. For those who still hold the product, identifying codes are UDI/DI B098008786190 and Lot Numbers: 230451. Distribution occurred nationwide across AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, and WA. Windstone Medical Packaging issued the recall for convenience kits containing Elevaris Lidocaine HCl injection USP after Elevaris Medical Devices Inc. recalled the injection due to supplier quality issues. The FDA designated the event as a Class II recall, defined by the agency as a category where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, and where the probability of serious adverse health consequences is remote. FDA enforcement database records show no other recall actions for Windstone Medical Packaging, Inc.
Aug 20, 2026, 7:41 a.m. ETFirst report
FDA Classifies Recall of Windstone Medical Convenience Kits
On August 5, 2026, FDA enforcement records classified an ongoing recall of medical convenience kits packaged by Billings-based Windstone Medical Packaging, Inc. as Class II. The action was initiated on June 17, 2026, under recall number Z-2819-2026, and affects a quantity of 15 kits distributed nationwide across AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, and WA.
The recall applies to AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as Port Tray - RX, Part Number 008786-19. Affected product identifiers include UDI/DI B098008786190 and Lot Numbers: 230451. Windstone Medical Packaging issued the recall for specific items and lots containing Elevaris Lidocaine HCl injection USP after Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Class II is the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA enforcement database records show no other recall actions for Windstone Medical Packaging, Inc.

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Version 120 Aug 2026, 11:41current
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Version 120 Aug 2026, 11:53current
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