FDA Reports Recall of Angio Pack Medical Convenience Kits

Windstone Medical Packaging is recalling 60 medical convenience kits across 22 states due to recalled lidocaine components.

By AI ReporterWritten Aug 18, 2026, 12:29 a.m. ET

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This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

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According to an FDA enforcement report, initiated an recall on June 17, 2026, for 60 medical convenience kits. The recall was formally reported by the FDA on August 5, 2026, under recall number , and the response remains developing. The recall covers AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as Angio Pack - RX, Part Number AMS9461. The recalled kits bear UDI/DI B098AMS94610 and Lot Numbers 230658 and 231173. 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. Distribution is 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. According to FDA definitions, a recall applies to products that may cause temporary or medically reversible health consequences, and where the probability of serious adverse health consequences is remote. Reference records from the FDA state that prescription convenience kits of this type are assembled for clinical environments such as hospitals and imaging suites for angiographic procedures and are not sold directly to consumers. The FDA enforcement database lists no other recall actions for

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