{"url_path":"/fda/device/recalls/Z-2595-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.    PICC LINEPACK (PCLUI)642-LF\t  \tDYNJ47717A","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-2595-2026%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":135,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2595-2026\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.    PICC LINEPACK (PCLUI)642-LF\t  \tDYNJ47717A\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\nDYNJ47717A    UDI-DI 10193489454529    Lots 21CMD153   21EMC033   21HMB521   21HMF278   21IME100   21IMG896   21JMG286   22AME235   22BMH056   22EMF125   22GMI215   22JME782   22LMC139   22LMC336\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."}