Medline Convenience Kits: 1) PAIN MGMT/ PREF W — Class II medical device recall Z-2534-2026
Ongoing recall by Medline Industries, LP, reported 2026-07-08, distributed nationwide. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recal
| Recall number | Z-2534-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-05-21 |
| Classified | 2026-06-29 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,512 kits |
| UPC / GTIN / UDI-DI | 10193489422443, 10195327486310, 10198459241215, 10198459342004, 10198459376177, 10198459478819, 10198459540639, 10198459544163, 10198459552809, 10888277797109, 40193489422444, 40195327486311, 40198459241216, 40198459342005, 40198459376178, 40198459478810, 40198459540630, 40198459544164, 40198459552800, 40888277797100 |
| Lot numbers | 25JDB100, 25JLA601, 25JLA659, 25JLA779, 25JLA781, 25JLA788, 25JLA861, 25JLA886, 25JLA928, 25JLA942 |
| Model numbers | PAIN0072L, PAIN1317, PAIN1579A, PAIN1885A, PAIN1967A, PAIN2269, PAIN2278, PAIN2305, PAIN2334, SAMPA0147 |
Product
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) 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
Reason for recall
The 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2534-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.