{"url_path":"/fda/device/recalls/Z-2490-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as:  ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-04","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2490-2026%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":119,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2490-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-04\n**Report date:** 2026-06-24\n\n## Product\nMEDLINE Medical Procedure Kits labeled as:  ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A\n\n## Reason\nDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.\n\n## Affected lots\nUDI/DI 10198459556654 (each), 40198459556655 (case). Lot Numbers:  25KBC063, 25JBO955.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI."}