FDA-Device2026-07-08Class IIPROCESSING DEFECT

Medline arterial access and line insertion kits recalled for Lidocaine quality defects

OTHERNationwide distributionMedical devices

What this means

Medline's arterial access and line insertion kits contain Lidocaine ampules from Huons Co., Ltd. that have quality defects. The defects were identified during an FDA inspection of the Lidocaine manufacturer's facility. The affected kits were distributed nationwide.

  • Check if your facility has any of the recalled kits (Model ART1145, ART155A, or ART1010B with lot numbers ending in 90, 0590, or 0890).
  • Do not use the Lidocaine ampules from the recalled kits.
  • Contact Medline for instructions on returning or replacing affected kits.
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
5,698 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2533-2026

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