{"url_path":"/fda/device/recalls/Z-3078-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    CATARACT PREOP KIT\t  \tDYKS1583A","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3078-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medline Industries, LP"},"word_count":104,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3078-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-20\n**Report date:** 2026-09-09\n\n## Product\nMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    CATARACT PREOP KIT\t  \tDYKS1583A\n\n## Reason\nDownstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.\n\n## Affected lots\nDYKS1583A    UDI-DI 10198459146640    Lot 24KBP388\n\n## Distribution\nUS Nationwide distribution."}