FDA-Device2026-07-08Class IIPROCESSING DEFECT
Medline Convenience Kits recalled for Lidocaine Ampule quality issues
What this means
Medline's Convenience Kits (Model DYNJRA1590) contain Lidocaine Ampules that were recalled by the manufacturer, Huons Co., Ltd., due to quality issues found during an FDA manufacturing inspection. About 270 kits were distributed nationwide.
- Check if you have Medline Convenience Kit Model DYNJRA1590 with Lot Number 25JLA522.
- Do not use the Lidocaine Ampules from affected kits.
- Contact your Medline representative or healthcare facility for instructions on return or replacement.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
270 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2535-2026More Medline recalls
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