Medline Suturing Set with Lidocaine Ampules Recalled
Medline Convenience Kits (Suturing Set, Model SUT13710) containing Huons Lidocaine HCL Injection USP are being recalled due to quality issues identified during an FDA manufacturing inspection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a drug component. The source text identifies quality issues but does not report any illnesses, injuries, or deaths, and does not specify the nature of the quality defect, making this a precautionary recall.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing a Suturing Set (Model Number SUT13710) that includes Huons Lidocaine HCL Injection USP 1% 10mg/ml in 5mL Ampules. The recall was initiated due to quality issues identified during a recent FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.
The affected product was distributed nationwide in the United States. The recalled lot includes 176 kits with Lot Number 2025102290.
Consumers or healthcare facilities in possession of the affected product should stop using it and contact Medline Industries, LP or the recalling firm for further instructions regarding return or replacement of the product.
The recalled product
- Product
- Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
- Manufacturer
- Medline Industries, LP
- Affected units
- 176
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 1) SUT13710
- UDI-DI: 00653160148527(each)
- 10653160148524(case)
- Lot Number: 2025102290
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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