{"url_path":"/fda/device/recalls/Z-2785-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    RR-DAVINCI PROSTATE ACCESSORY\t  \tDYNJ63392F","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-08","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2785-2026%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":128,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2785-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-08\n**Report date:** 2026-07-29\n\n## Product\nMedline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    RR-DAVINCI PROSTATE ACCESSORY\t  \tDYNJ63392F\n\n## Reason\nAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.\n\n## Affected lots\nDYNJ63392F    UDI-DI 10198459315572    Lots 25GLA905   25HLA240   25HLA894   25JLA091   25KLA775   25LLA985   26ALA670\n\n## Distribution\nUS Nationwide distribution in the states of CA, FL, MD. PA, and TX."}