{"url_path":"/fda/device/recalls/Z-2534-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L;  2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317;  3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A;  4) CSE TRAY, Model Number: PAIN1885A;  5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A;  6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269;  7) EPIDU…","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-2534-2026%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":233,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2534-2026\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) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L;  2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317;  3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A;  4) CSE TRAY, Model Number: PAIN1885A;  5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A;  6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269;  7) EPIDURAL TRAY, Model Number: PAIN2278;  8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305;  9) CSE TRAY MEDLINE, Model Number: PAIN2334;  10) PNBT TRAY, Model Number: SAMPA0147\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) PAIN0072L, UDI-DI: 10198459544163(each), 40198459544164(case), Lot Number: 25JDB100; 2) PAIN1317, UDI-DI: 10888277797109(each), 40888277797100(case), Lot Number: 25JLA788; 3) PAIN1579A, UDI-DI: 10193489422443(each), 40193489422444(case), Lot Number: 25JLA779; 4) PAIN1885A, UDI-DI: 10195327486310(each), 40195327486311(case), Lot Number: 25JLA861; 5) PAIN1967A, UDI-DI: 10198459241215(each), 40198459241216(case), Lot Number: 25JLA659; 6) PAIN2269, UDI-DI: 10198459342004(each), 40198459342005(case), Lot Number: 25JLA781; 7) PAIN2278, UDI-DI: 10198459376177(each), 40198459376178(case), Lot Number: 25JLA886; 8) PAIN2305, UDI-DI: 10198459478819(each), 40198459478810(case), Lot Number: 25JLA601; 9) PAIN2334, UDI-DI: 10198459540639(each), 40198459540630(case), Lot Number: 25JLA942; 10) SAMPA0147, UDI-DI: 10198459552809(each), 40198459552800(case), Lot Number: 25JLA928;\n\n## Distribution\nUS Nationwide distribution."}