{"url_path":"/fda/device/recalls/Z-3024-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline convenience kits labeled as:    1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C;   2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166;   3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B;   4) EAST DAVINCI, Medline Kit SKU DYNJ900949C;   5) THORACIC, Medline Kit SKU DYNJ903470G;   6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G;   7) GENERAL ROBOTIC, Med…","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-3024-2026%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":423,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3024-2026\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) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C;   2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166;   3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B;   4) EAST DAVINCI, Medline Kit SKU DYNJ900949C;   5) THORACIC, Medline Kit SKU DYNJ903470G;   6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G;   7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A;   8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B;   9) DIEP FLAP, Medline Kit SKU DYNJ910832A;   10) C-SECTION, Medline Kit SKU DYNJ911236;   11) LAPAROTOMY, Medline Kit SKU DYNJ911243;   12) OPEN HEART A&B, Medline Kit SKU DYNJ911245;   13) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332;   14) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332A.\n\n## Reason\nKits contain a potentially contaminated component which were recalled by the manufacturer\n\n## Affected lots\nMedline Kit SKU DYNJG001030C, UDI/DI 10198459729614 (each) 40198459729615 (case), Lot Number 26CLA636;  Medline Kit SKU DYNJT8166, UDI/DI 10198459697739 (each) 40198459697730 (case), Lot Number 26DBG173;  Medline Kit SKU DYNJT8166, UDI/DI 10198459697739 (each) 40198459697730 (case), Lot Number 26CBT177;  Medline Kit SKU DYNJ47638B, UDI/DI 10198459219221 (each) 40198459219222 (case), Lot Number 26DBL480;  Medline Kit SKU DYNJ47638B, UDI/DI 10198459219221 (each) 40198459219222 (case), Lot Number 26CBQ902;  Medline Kit SKU DYNJ900949C, UDI/DI 10195327076344 (each) 40195327076345 (case), Lot Number 25IBR180;  Medline Kit SKU DYNJ903470G, UDI/DI 10195327678562 (each) 40195327678563 (case), Lot Number 26ADA465;  Medline Kit SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot Number 25LBU940;  Medline Kit SKU DYNJ910178A, UDI/DI 10198459320682 (each) 40198459320683 (case), Lot Number 25IBU845;  Medline Kit SKU DYNJ910281B, UDI/DI 10198459586385 (each) 40198459586386 (case), Lot Number 26ABI051;  Medline Kit SKU DYNJ910832A, UDI/DI 10198459425653 (each) 40198459425654 (case), Lot Number 25KBH197;  Medline Kit SKU DYNJ911236, UDI/DI 10198459302299 (each) 40198459302290 (case), Lot Number 26BBB487;  Medline Kit SKU DYNJ911236, UDI/DI 10198459302299 (each) 40198459302290 (case), Lot Number 25IBS529;  Medline Kit SKU DYNJ911243, UDI/DI 10198459302329 (each) 40198459302320 (case), Lot Number 26CBM128;  Medline Kit SKU DYNJ911243, UDI/DI 10198459302329 (each) 40198459302320 (case), Lot Number 25JBI549;  Medline Kit SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot Number 25IBP079;  Medline Kit SKU DYNJ911332, UDI/DI 10198459326103 (each) 40198459326104 (case), Lot Number 25LBC312;  Medline Kit SKU DYNJ911332, UDI/DI 10198459326103 (each) 40198459326104 (case), Lot Number 25KBM427;  Medline Kit SKU DYNJ911332A, UDI/DI 10198459714511 (each) 40198459714512 (case), Lot Number 26DBO888;  Medline Kit SKU DYNJ911332A, UDI/DI 10198459714511 (each) 40198459714512 (case), Lot Number 26DBF153.\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."}