{"url_path":"/fda/device/recalls/Z-2619-2026","section_key":"summary","section_title":"DEVICE Recall: Windstone Medical Packaging, Inc. — A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2619-2026%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":114,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2619-2026\n\n**Recalling firm:** Windstone Medical Packaging, Inc.\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-21\n**Report date:** 2026-07-08\n\n## Product\nA M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit\n\n## Reason\nKits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.\n\n## Affected lots\nUDI/DI none, Lot Codes:  237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.\n\n## Distribution\nUS Nationwide distribution in the states of PA, GA, CA, WA."}