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FDA
Food and Drug Administration · Recall Z-2816-2026 · Jun 17, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B

Windstone Medical Packaging, Inc.

The hazard

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. FDA Class II recall.

The remedy

Follow FDA guidance

About this recall

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B

Affected identifiers

Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.

Model UDI/DI B098DDS1159B0Model Lot Numbers: 214412.

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.