FDA Medical devices recall ·
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710 recall
- Recall number
- Z-2540-2026
- Date
- (initiated May 21, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 176 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) SUT13710, UDI-DI: 00653160148527(each), 10653160148524(case), Lot Number: 2025102290
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2540-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.