FDA-Device2026-07-08Class IIPROCESSING DEFECT

Medline circumcision trays recalled for defective lidocaine ampules

OTHERNationwide distributionMedical devices

What this means

Medline Industries is recalling three models of circumcision procedure kits because they contain lidocaine ampules with quality issues. The ampules were made by Huons Co., Ltd. and problems were found during an FDA manufacturing inspection. No injuries have been reported.

  • Check if you have one of the affected kits (Model CIT6780, CIT3225A, or CIT6325).
  • Do not use kits with the recalled lot numbers (2025102790, 2025102190, or 2025102390).
  • Contact Medline or your medical supplier for instructions on returning or replacing the 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
512 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2546-2026

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