{"url_path":"/fda/device/recalls/Z-2813-2026","section_key":"summary","section_title":"DEVICE Recall: Windstone Medical Packaging, Inc. — AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:    1)\tDr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ;   2)\tSingle Shot Epidural Tray - RX, Part Number AMS11296A;   3)\tNerve Block Tray - RX, Part Number AMS11314A;   4)\tEpidural Tray - RX, Part Number AMS11910A;   5)\tNerve Block Tray - RX, Part Number AMS12171;   …","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-2813-2026%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":240,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2813-2026\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:    1)\tDr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ;   2)\tSingle Shot Epidural Tray - RX, Part Number AMS11296A;   3)\tNerve Block Tray - RX, Part Number AMS11314A;   4)\tEpidural Tray - RX, Part Number AMS11910A;   5)\tNerve Block Tray - RX, Part Number AMS12171;   6)\tSingle Shot Epidural Tray - RX, Part Number AMS12219A;   7)     Universal Block Tray - RX, Part Number AMS12381B.\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\nPart Number AMS1095(E, UDI/DI B098AMS1095(E0;  Lot Numbers: 231043;  Part Number AMS11296A, UDI/DI B098AMS11296A0;  Lot Numbers: 229846;  Part Number AMS11314A, UDI/DI B098AMS11314A0;  Lot Numbers: 216803, 240843;  Part Number AMS11910A, UDI/DI B098AMS11910A0;  Lot Numbers: 230645, 231078;  Part Number AMS12171, UDI/DI B098AMS121710;  Lot Numbers: 230958, 231238, 241232;  Part Number AMS12219A, UDI/DI B098AMS12219A0;  Lot Numbers: 217313;  Part Number AMS12381B, UDI/DI B098AMS12381B0;  Lot Numbers: 230948.\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."}