Medline Lumbar Puncture Kit recalled for Lidocaine quality issues
Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% ampules are being recalled due to quality issues identified during an FDA manufacturing inspection. Affected kits have been distributed nationwide.
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 identifies only unspecified quality issues from a manufacturing inspection with no reported illnesses or injuries, placing this in the moderate category as a precautionary recall without evidence of harm.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits (Model DYNDH1215, Lot 2025092390) containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL ampules. A recall notice was issued by Huons Co., Ltd. for the Lidocaine ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
The affected kits have been distributed nationwide. Approximately 420 kits were involved. Healthcare facilities and providers who received these kits should immediately stop using them.
Patients and healthcare providers with questions about this recall should contact the manufacturer or their supplier for guidance on proper handling and replacement options.
The recalled product
- Product
- Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
- Manufacturer
- Medline Industries, LP
- Affected units
- 420
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) DYNDH1215
- UDI-DI: 10889942550876(each)
- 40889942550877(case)
- Lot Number: 2025092390
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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