{"url_path":"/fda/device/recalls/Z-2788-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical convenience kits labeled as:    1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B;   2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-11","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2788-2026%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":155,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2788-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-11\n**Report date:** 2026-07-29\n\n## Product\nMedline medical convenience kits labeled as:    1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B;   2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.\n\n## Reason\nMedline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.\n\n## Affected lots\nMedline Kit SKU DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237;  Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761;  Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25BBD107;  Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBD534;  Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBL772.\n\n## Distribution\nUS:  CT, FL, KS, OH, OR, NY, MD, MT, VA, MA."}