The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2541-2026·Announced 2026-07-08

Medline Convenience Kits Recalled Due to Lidocaine Quality Issues

Medline Industries is recalling multiple convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II medical device recall (as indicated by the agency classification) involving a drug component with identified quality issues. No specific illnesses, injuries, or adverse events are reported in the source text, making this a moderate-severity precautionary recall driven by manufacturing quality defects rather than confirmed harm.

Plain-English summary

Medline Industries, LP is recalling 48,075 convenience kits distributed nationwide that contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules. The kits affected span 70+ model numbers and include central venous catheter insertion bundles, arterial catheter kits, dialysis kits, biopsy trays, and laceration trays, among others.

A recall notice was issued by Huons Co., Ltd. for the Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of Huons' drug manufacturing site. The specific nature of the quality defects is not detailed in the available recall information.

Consumers and healthcare providers in possession of affected kits should stop use and contact Medline Industries for instructions on return or replacement. The FDA and Medline are working to address the quality concerns related to the lidocaine component.

The recalled product

Product
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH…
Manufacturer
Medline Industries, LP
Category
Medical Device — Central Venous Catheter and Procedural Kits
Hazard
Affected units
48,075

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) ECVC8520
  • UDI-DI: 10653160375104(each)
  • 00653160375107(case)
  • Lot Number: 2026031790
  • 2) CVI4880B
  • UDI-DI: 10653160377191(each)
  • 00653160377194(case)
  • Lot Number: 2026021190
  • 3) ART356
  • UDI-DI: 10653160375371(each)
  • 00653160375374(case)
  • Lot Number: 2026011990
  • 4) STCVC03
  • UDI-DI: 10653160365235(each)
  • 00653160365238(case)
  • 5) ARTNC217
  • UDI-DI: 10653160383352(each)
  • 00653160383355(case)
  • Lot Number: 2025121190
  • 6) ECVC1720

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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