FDA-Device2026-07-08Class IIPROCESSING DEFECT
Medline Ophthalmic Pack with Lidocaine recalled for quality issues
What this means
Medline's Ophthalmic Pack with Lidocaine (Model DYNJ57922A) contains lidocaine ampules manufactured by Huons Co., Ltd. that have quality issues identified during an FDA inspection of the manufacturing facility. About 180 kits were distributed nationwide.
- Check if you have this kit (Model DYNJ57922A, Lot 25JLA852)
- Contact Medline or your healthcare facility for instructions on handling affected kits
- Do not use the lidocaine ampules until you receive guidance
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
180 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2547-2026More Medline recalls
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