FDA recall Z-2816-2026

Windstone Medical Packaging, Inc. · Class II · device

Product

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

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.

Distribution

US 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, WA.

Key facts

Status: Ongoing
Initiation date: 2026-06-17
Report date: 2026-08-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Billings, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2816-2026