{"url_path":"/fda/device/recalls/Z-3020-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline convenience kits labeled as:    1) OPEN HEART PACK, Medline Kit SKU CDS840393P;   2) OPEN HEART PACK, Medline Kit SKU CDS840393Q;   3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W;   4) VALVE CDS, Medline Kit SKU CDS981551G;   5) FEM POP, Medline Kit SKU CDS982028W;   6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F;   7) PACK,CLOSED HEART, Medli…","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-3020-2026%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":352,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3020-2026\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) OPEN HEART PACK, Medline Kit SKU CDS840393P;   2) OPEN HEART PACK, Medline Kit SKU CDS840393Q;   3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W;   4) VALVE CDS, Medline Kit SKU CDS981551G;   5) FEM POP, Medline Kit SKU CDS982028W;   6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F;   7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C;   8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F;   9) OPEN HEART, Medline Kit SKU DYNJ910947;   10) CV, Medline Kit SKU DYNJ911488.\n\n## Reason\nKits contain a potentially contaminated component which were recalled by the manufacturer\n\n## Affected lots\nMedline Kit SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26FMA487;  Medline Kit SKU CDS840393Q, UDI/DI 10198459791673 (each) 40198459791674 (case), Lot Number 26GMA017;  Medline Kit SKU CDS980895W, UDI/DI 10198459123542 (each) 40198459123543 (case), Lot Number 25LMG706;  Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBY147;  Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBR361;  Medline Kit SKU CDS982028W, UDI/DI 10198459385605 (each) 40198459385606 (case), Lot Number 25LMH727;  Medline Kit SKU DYNJ906903F, UDI/DI 10198459504877 (each) 40198459504878 (case), Lot Number 25JME689;  Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25JMF804;  Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25IMG539;  Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA930;  Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA516;  Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA196;  Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25KLA552;  Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25KBD555;  Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25JBS919;  Medline Kit SKU DYNJ910947, UDI/DI 10198459208928 (each) 40198459208929 (case), Lot Number 25JBM122;  Medline Kit SKU DYNJ911488, UDI/DI 10198459361616 (each) 40198459361617 (case), Lot Number 25KBF034.\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."}