- Recalling firm
- Medline Industries, LP
- 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.
- Affected products (lot / model / serial)
- 1) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2026031190; 2) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025120590; 3) MNS9715, UDI-DI: 10653160292029(each), 00653160292022(case), Lot Number: 2025120890; 4) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025120990; 5) P155615A, UDI-DI: 10889942219889(each), 40889942219880(case), Lot Number: 2025120890; 6) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025102790; 7) SUT18660A, UDI-DI: 10653160359302(each), 00653160359305(case), Lot Number: 2025120890; 8) MNS5985, UDI-DI: 00653160204407(each), 10653160204404(case), Lot Number: 2025120590; 9) DYNDL1351, UDI-DI: 10884389278352(each), 40884389278353(case), Lot Number: 2025120190; 10) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025112690; 11) ART600, UDI-DI: 10653160312727(each), 00653160312720(case), Lot Number: 2025112690; 12) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2025112690; 13) SUT9710C, UDI-DI: 10653160331254(each), 00653160331257(case), Lot Number: 2025103090; 14) ID2060, UDI-DI: 10653160310006(each), 00653160310009(case), Lot Number: 2025101790; 15) SUT12265, UDI-DI: 00653160130898(each), 10653160130895(case), Lot Number: 2025102390; 16) DYNDH1466, UDI-DI: 10193489193756(each), 20193489193753(case), Lot Number: 2025102190; 17) MNS5985, UDI-DI: 00653160204407(each), 10653160204404(case), Lot Number: 2025101690; 18) SUT19665, UDI-DI: 10653160288572(each), 00653160288575(case), Lot Number: 2025102490; 19) P124863, UDI-DI: 10889942140787(each), 40889942140788(case), Lot Number: 2025102090; 20) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025101090; 21) SUT18660A, UDI-DI: 10653160359302(each), 00653160359305(case), Lot Number: 2025092690; 22) ART352, UDI-DI: 10653160323747(each), 00653160323740(case), Lot Number: 2025100790; 23) DYNDH1699, UDI-DI: 10653160349914(each), 00653160349917(case), Lot Number: 2025092590; 24) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2025092690; 25) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025091590; 26) SPEC0070B, UDI-DI: 10193489196627(each), 20193489196624(case), Lot Number: 2025100890; 27) SUT4155, UDI-DI: 00653160008760(each), 50653160008765(case), Lot Number: 2025100990; 28) SUT16080, UDI-DI: 00653160225051(each), 10653160225058(case), Lot Number: 2025092690; 29) DYNDH1213, UDI-DI: 10653160383864(each), 00653160383867(case), Lot Number: 2025091990; 30) P155615A, UDI-DI: 10889942219889(each), 40889942219880(case), Lot Number: 2025090490; 31) SUT12265, UDI-DI: 00653160130898(each), 10653160130895(case), Lot Number: 2025090590
- Units affected
- 15662 kits
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2542-2026
- Recall initiated
- May 21, 2026
- FDA classification date
- June 29, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99162
- Last updated on HTM Vibe
- July 23, 2026