{"url_path":"/fda/device/recalls/Z-2812-2026","section_key":"summary","section_title":"DEVICE Recall: Windstone Medical Packaging, Inc. — AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  SPINAL KIT, Part Number AMS13683A","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-17","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2812-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Windstone Medical Packaging, Inc."},"word_count":121,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2812-2026\n\n**Recalling firm:** Windstone Medical Packaging, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-17\n**Report date:** 2026-08-05\n\n## Product\nAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  SPINAL KIT, Part Number AMS13683A\n\n## Reason\nWindstone 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.\n\n## Affected lots\nUDI/DI B098AMS13683A0, Lot Number  230451\n\n## Distribution\nUS 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."}