{"url_path":"/fda/device/recalls/Z-2780-2026","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.    DAVINCI PROSTATE PACK\t  \tDYNJ68477L  \tDYNJ68477M","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-2780-2026%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":130,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2780-2026\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.    DAVINCI PROSTATE PACK\t  \tDYNJ68477L  \tDYNJ68477M\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\nDYNJ68477L    UDI-DI 10198459487866    Lots 25HMF458   25LME235  DYNJ68477M    UDI-DI 10198459678738    Lots 26CMK219   26EMG622\n\n## Distribution\nUS Nationwide distribution in the states of CA, FL, MD. PA, and TX."}