{"url_path":"/fda/device/recalls/Z-2495-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as:    1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C;   2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978;   3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.","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-2495-2026%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":221,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2495-2026\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:    1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C;   2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978;   3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.\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\nMedline Kit Number/SKU DYKMBNDL117C:  UDI/DI 10195327371104 (each), 40195327371105 (case), Lot Number 23DLA834;  Medline Kit Number/SKU DYNJ908978:  UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23BMC463;  Medline Kit Number/SKU DYNJ908978:  UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMA685;  Medline Kit Number/SKU DYNJ908978:  UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMB905;  Medline Kit Number/SKU DYNJ908978:  UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMG466;  Medline Kit Number/SKU DYNJ908978:  UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMB983;  Medline Kit Number/SKU DYNJ908978F:  UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25JBD225;  Medline Kit Number/SKU DYNJ908978F:  UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25HBW236.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI."}