{"url_path":"/fda/device/recalls/Z-2765-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — MEDLINE medical procedure convenience kit labeled as:   1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T;  2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U;  3) TOTAL KNEE CDS, Medline kit SKU CDS983930J;  4) HIP CDS-LF, Medline kit SKU CDS984556L;  5) HIP CDS-LF, Medline kit SKU CDS984556M;  6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-08","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2765-2026%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":326,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2765-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-08\n**Report date:** 2026-07-29\n\n## Product\nMEDLINE medical procedure convenience kit labeled as:   1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T;  2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U;  3) TOTAL KNEE CDS, Medline kit SKU CDS983930J;  4) HIP CDS-LF, Medline kit SKU CDS984556L;  5) HIP CDS-LF, Medline kit SKU CDS984556M;  6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.\n\n## Reason\nThe procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.\n\n## Affected lots\nMedline kit SKU CDSOPT590T, UDI/DI 10195327555009 (each) 40195327555000 (case), Kit Lot Number  24GDA740;  Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number  26EDA279;  Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number  26BDB734;  Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number  26ADA474;  Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number  25LDA001;  Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number  25KDB325;  Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number  25GDB517;  Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number  25FDB017;  Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number  25DDA155;  Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number  24LDA248;  Medline kit SKU CDS983930J, UDI/DI 10193489512298 (each) 40193489512299 (case), Kit Lot Number  25KBL209;  Medline kit SKU CDS984556L, UDI/DI 10195327554996 (each) 40195327554997 (case), Kit Lot Number  24JDC180;  Medline kit SKU CDS984556L, UDI/DI 10195327554996 (each) 40195327554997 (case), Kit Lot Number  24HDA321;  Medline kit SKU CDS984556M, UDI/DI 10198459180248 (each) 40198459180249 (case), Kit Lot Number  25ADB327;  Medline kit SKU DYNJ905162Q, UDI/DI 10198459235900 (each) 40198459235901 (case), Kit Lot Number  26CBD346;  Medline kit SKU DYNJ905162Q, UDI/DI 10198459235900 (each) 40198459235901 (case), Kit Lot Number  25KBU219.\n\n## Distribution\nUS:  Mo, CO, IL"}