FDA recall Z-2540-2026

Product

Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2026-05-21

Report date

2026-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2540-2026