{"url_path":"/fda/device/recalls/Z-2106-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits:  1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A;   2) CHEST/BREAST-LF, Model Number: DYNJ83950;   3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A;   4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-01-07","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2106-2026%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":291,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2106-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-01-07\n**Report date:** 2026-05-13\n\n## Product\nMedline Convenience Kits:  1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A;   2) CHEST/BREAST-LF, Model Number: DYNJ83950;   3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A;   4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C\n\n## Reason\nMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.\n\n## Affected lots\n1) DYNDA2941A, UDI-DI: 10195327331795(each), 40195327331796(case), Lot Number: 23BMB940; 2) DYNDA2941A, UDI-DI: 10195327331795(each), 40195327331796(case), Lot Number: 23FMF503; 3) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23CBG610; 4) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23FBF248; 5) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23LBR075; 6) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24CBH626; 7) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24DBT832; 8) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 23KBM234; 9) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 23KBO757; 10) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 23LBQ441; 11) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 24BBG312; 12) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 24EBM141; 13) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24HBW695; 14) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24IBN719; 15) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24KBK455; 16) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25ABG235; 17) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25BBO546; 18) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25DBG687; 19) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25DBQ261; 20) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25FBF535; 21) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25FBW469; 22) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25GBV755\n\n## Distribution\nWorldwide - US Nationwide distribution."}