{"url_path":"/fda/device/recalls/Z-2479-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes:    1.\tDYND13508 - 08 Fr;  2.\tDYND13510 - 10 Fr;  3.\tDYND13512 - 12 Fr;  4.\tDYND13514 - 14 Fr;  5.\tDYND13515 - 15 Fr;  6.\tDYND13516 - 16 Fr;  7.\tDYND13518 - 18 Fr;  8.\tDYND13520 - 20 Fr;  9.\tDYND13522 - 22 Fr;  10.\tDYND13614 - 14 Fr;  11.\tDYND13616 - 16 Fr.","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-2479-2026%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":245,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2479-2026\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 Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes:    1.\tDYND13508 - 08 Fr;  2.\tDYND13510 - 10 Fr;  3.\tDYND13512 - 12 Fr;  4.\tDYND13514 - 14 Fr;  5.\tDYND13515 - 15 Fr;  6.\tDYND13516 - 16 Fr;  7.\tDYND13518 - 18 Fr;  8.\tDYND13520 - 20 Fr;  9.\tDYND13522 - 22 Fr;  10.\tDYND13614 - 14 Fr;  11.\tDYND13616 - 16 Fr.\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\n1. DYND13508, UDI/DI 10080196031139 (each), 20080196031136 (case);  2. DYND13510, UDI/DI 10080196726462 (each), 40080196726463 (case);  3. DYND13512, UDI/DI 10080196031177 (each), 40080196031178 (case);  4. DYND13514, UDI/DI 10080196726219 (each), 40080196726210 (case);  5. DYND13515, UDI/DI 10080196031214 (each), 40080196031215 (case);  6. DYND13516, UDI/DI 10080196031221 (each), 40080196031222 (case);  7. DYND13518, UDI/DI 10080196031245 (each), 40080196031246 (case);  8. DYND13520, UDI/DI 10080196031252 (each), 40080196031253 (case);  9. DYND13522, UDI/DI 10080196061259 (each), 40080196061250 (case);  10. DYND13614, UDI/DI 10080196031276 (each), 30080196031270 (case);  11. DYND13616, UDI/DI 10888277720879 (each), 20888277720876 (case);  ALL LOTS\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI."}