{"url_path":"/fda/device/recalls/Z-2124-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits:  1) DRAPE PACK, Model Number: DYNJ35363A;   2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-01-07","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2124-2026%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":118,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2124-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-01-07\n**Report date:** 2026-05-13\n\n## Product\nMedline Convenience Kits:  1) DRAPE PACK, Model Number: DYNJ35363A;   2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005\n\n## Reason\nMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.\n\n## Affected lots\n1) DYNJ35363A, UDI-DI: 10884389516461(each), 40884389516462(case), Lot Number: 21BBP020; 2) SPTPCD10005, UDI-DI: 10080196228652(each), 40080196228653(case), Lot Number: 24JBB041\n\n## Distribution\nWorldwide - US Nationwide distribution."}