{"url_path":"/fda/device/recalls/Z-2789-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical convenience kits labeled as:    1) SHOULDER PACK, Medline Kit SKU DYNJ39590O;   2) SHOULDER PACK, Medline Kit SKU DYNJ88566;   3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.","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-2789-2026%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":183,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2789-2026\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) SHOULDER PACK, Medline Kit SKU DYNJ39590O;   2) SHOULDER PACK, Medline Kit SKU DYNJ88566;   3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.\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 DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25GBE239;  Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 24LBF187;  Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25ABM992;  Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25CBJ129;  Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25DBI743;  Medline Kit SKU DYNJ88566, UDI/DI 10198459179235 (each) 40198459179236 (case), Lot Number 24KBK487;  Medline Kit SKU DYNJ911535, UDI/DI 10198459377600 (each) 40198459377601 (case), Lot Number 25FBU802.\n\n## Distribution\nUS:  CT, FL, KS, OH, OR, NY, MD, MT, VA, MA."}