Z-2540-2026 Class II Ongoing
FDA device recall Z-2540-2026 was initiated by Medline Industries, LP on May 21, 2026 and is designated Class II. 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 identif… The recall status is ongoing. Affected quantity: 176 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- May 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 176 kits
Product Description
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 Pattern
US Nationwide distribution.
Code Information
1) SUT13710, UDI-DI: 00653160148527(each), 10653160148524(case), Lot Number: 2025102290