Reported Jul 8, 2026 · Ongoing

Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER…

Medline Industries, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

  • Medline Convenience Kits
    • 1) STD
    • INTRO-FLEX INTRODUCER 6F
    • C
  • Model Number
    • I550BF6C
    • 2) STD
    • INTRO-FLEX INTRODUCER 9F
    • C
  • Model NumberI505BF9C
Lot codes and dates
  • 1) I550BF6C
  • UDI-DI
    • 10653160339748(each)
    • 00653160339741(case)
  • Lot Number
    • 2025102290
    • 2) I505BF9C
  • UDI-DI
    • 10653160339687(each)
    • 00653160339680(case)
  • Lot Number2025093090
Amount recalled
510 kits

This recall covers 24 products

The agency filed one notice per product. You are reading one of them; the other 23 are below.

11 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.