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FDAFDA · Food and drugs·Recall number Z-2537-2026

Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK

Published July 8, 2026 · Recall initiated: May 21, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Medline Industries, LP
Distributor
US Nationwide distribution.
Lot
1) DYNJ0621189X, UDI-DI: 10195327638566(each), 40195327638567(case), Lot Number: 25ILA890; 2) PAIN1470A, UDI-DI: 10193489957365(each), 40193489957366(case), Lot Number: 25JLA514; 3) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25JDB583; 4) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDA180; 5) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDB274
Risk classification
Class II
Area (FDA)
device
Country
United States

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