{"url_path":"/fda/device/recalls/Z-2781-2026","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.    \t  UROLOGY ROBOTIC PROCEDURE PACK\t  \tDYNJ0945779U","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-2781-2026%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":126,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2781-2026\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.    \t  UROLOGY ROBOTIC PROCEDURE PACK\t  \tDYNJ0945779U\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\nDYNJ0945779U    UDI-DI 10195327632656    Lots 25IMC004   25JMD942   25JMJ441   25LMG068\n\n## Distribution\nUS Nationwide distribution in the states of CA, FL, MD. PA, and TX."}