Medline Circumcision Trays recalled due to Lidocaine quality issues
Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.
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: The FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or adverse events—only quality issues identified during inspection. This makes it a precautionary recall without evidence of harm, consistent with a Moderate severity score.
Plain-English summary
Medline Industries, LP is recalling three models of circumcision convenience kits that contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL ampules. The recall was initiated following quality issues identified during a recent FDA manufacturing inspection of Huons Co., Ltd., the drug manufacturer.
The affected kits are: (1) MERCY MEDICAL CIRCUMCISION TRAY, Model CIT6780, Lot 2025102790; (2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model CIT3225A, Lot 2025102190; and (3) CIRCUMCISION TRAY, Model CIT6325, Lot 2025102390. A total of 512 kits were distributed nationwide.
Healthcare providers and facilities that received these kits should stop using them and contact Medline Industries for replacement or further instructions. Patients who have questions about their care should consult their healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- Medline Industries, LP
- Affected units
- 512
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 (12)
- 1) CIT6780
- UDI-DI: 10653160324232(each)
- 00653160324235(case)
- Lot Number: 2025102790
- 2) CIT3225A
- UDI-DI: 00653160165142(each)
- 10653160165149(case)
- Lot Number: 2025102190
- 3) CIT6325
- UDI-DI: 10653160294160(each)
- 00653160294163(case)
- Lot Number: 2025102390
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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