{"url_path":"/fda/device/recalls/Z-2546-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits:  1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780;   2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A;   3) CIRCUMCISION TRAY, Model Number: CIT6325","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2546-2026%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":127,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2546-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-21\n**Report date:** 2026-07-08\n\n## Product\nMedline Convenience Kits:  1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780;   2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A;   3) CIRCUMCISION TRAY, Model Number: CIT6325\n\n## Reason\nThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.\n\n## Affected lots\n1) CIT6780, UDI-DI: 10653160324232(each), 00653160324235(case), Lot Number: 2025102790; 2) CIT3225A, UDI-DI: 00653160165142(each), 10653160165149(case), Lot Number: 2025102190; 3) CIT6325, UDI-DI: 10653160294160(each), 00653160294163(case), Lot Number: 2025102390\n\n## Distribution\nUS Nationwide distribution."}