{"url_path":"/fda/device/recalls/Z-2779-2026","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.    KIT ROBOTICS UROLOGY PROSTATE\t  \tDYKMBNDL116I","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-2779-2026%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":124,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2779-2026\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.    KIT ROBOTICS UROLOGY PROSTATE\t  \tDYKMBNDL116I\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\nDYKMBNDL116I    UDI-DI 10198459644764    Lots 26ABL226   26BBD710\n\n## Distribution\nUS Nationwide distribution in the states of CA, FL, MD. PA, and TX."}