FDA-Device2026-07-08Class IIPROCESSING DEFECT

Medline Convenience Kits recalled for contaminated lidocaine ampules

OTHERNationwide distributionMedical devices

What this means

Medline Convenience Kits containing Huons Lidocaine HCL Injection ampules are being recalled due to quality issues found during an FDA manufacturing inspection. The affected kits include two introducer models (6F and 9F) distributed nationwide. No injuries have been reported.

  • Check if you have Medline Convenience Kits Model I550BF6C (Lot 2025102290) or Model I505BF9C (Lot 2025093090).
  • Do not use the lidocaine ampules in these kits.
  • Contact Medline Industries or your supplier 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
510 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2538-2026

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