{"url_path":"/fda/device/recalls/Z-3028-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline convenience kits labeled as:    1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F;   2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C;   3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B;   4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-10","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3028-2026%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":190,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3028-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-10\n**Report date:** 2026-09-02\n\n## Product\nMedline convenience kits labeled as:    1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F;   2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C;   3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B;   4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.\n\n## Reason\nKits contain a potentially contaminated component which were recalled by the manufacturer\n\n## Affected lots\nMedline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986;  Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case), Lot Number 25IBP434;  Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 26BBA665;  Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25KBR602;  Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25JBH531;  Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25KBL876;  Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25JBS218.\n\n## Distribution\nUS Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI."}