{"url_path":"/fda/device/recalls/Z-2127-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits:  1) ARTHROSCOPY CDS, Model Number: CDS984609B;   2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G;   3) ARTHROSCOPY PACK, Model Number: DYNJ32715F;   4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C;   5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069","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-2127-2026%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":223,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2127-2026\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) ARTHROSCOPY CDS, Model Number: CDS984609B;   2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G;   3) ARTHROSCOPY PACK, Model Number: DYNJ32715F;   4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C;   5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069\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) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 21JBJ732; 2) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22ABJ831; 3) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22BBD031; 4) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22FBP788; 5) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBE795; 6) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBF936; 7) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBJ847; 8) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBL738; 9) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21ABK153; 10) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21CBZ902; 11) DYNJ32715F, UDI-DI: 10889942530038(each), 40889942530039(case), Lot Number: 21ADB529; 12) DYNJ50834C, UDI-DI: 10889942568178(each), 40889942568179(case), Lot Number: 21BDA710; 13) DYNJ51069, UDI-DI: 10889942118410(each), 40889942118411(case), Lot Number: 21BDB116\n\n## Distribution\nWorldwide - US Nationwide distribution."}