{"url_path":"/fda/device/recalls/Z-2589-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.    KIT NEURO CSTM\t  \tSAMP0551","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-02-27","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2589-2026%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":123,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2589-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-02-27\n**Report date:** 2026-07-01\n\n## Product\nConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.    KIT NEURO CSTM\t  \tSAMP0551\n\n## Reason\nFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA.  Products not initially reported in RES 98601.\n\n## Affected lots\nSAMP0551    UDI-DI 10195327268503    Lots 22JBG593   22JBJ361\n\n## Distribution\nUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS,  KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI,  WY and the country of Barbados."}