{"url_path":"/fda/device/recalls/Z-2307-2026","section_key":"summary","section_title":"DEVICE Recall: Windstone Medical Packaging, Inc. — Aligned Medical AMS16835 Fluids Kit   RX","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-27","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2307-2026%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":79,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2307-2026\n\n**Recalling firm:** Windstone Medical Packaging, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-27\n**Report date:** 2026-06-10\n\n## Product\nAligned Medical AMS16835 Fluids Kit   RX\n\n## Reason\nLidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.\n\n## Affected lots\nUDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935\n\n## Distribution\nUS Nationwide distribution in the states of IL, VA."}