Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
Medline Industries is recalling Imaging Biopsy Tray and Breast Biopsy Pack kits containing Huons Lidocaine HCL Injection USP 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: The source is classified as FDA Class II. No illnesses, injuries, or specific hazard details are reported in the source text—only generic "quality issues" identified during inspection. The recall is precautionary.
Plain-English summary
Medline Industries, LP is recalling two Medline Convenience Kits: the Imaging Biopsy Tray (Model Number DYNDH1068, Lot Number 2025101090) and the Breast Biopsy Pack (Model Number PHS234706I, Lot Number 25JLB029). These kits contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules supplied as original equipment manufacturer (OEM) components.
The recall was initiated by Huons Co., Ltd. following quality issues discovered during a recent FDA manufacturing inspection of their drug manufacturing facility. A total of 40 kits have been distributed nationwide in the United States.
Patients and healthcare providers who have these products should discontinue use. Consult with healthcare providers regarding alternative treatment options.
The recalled product
- Product
- Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Biopsy Kit
- Hazard
- Affected units
- 40
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 (8)
- 1) DYNDH1068
- UDI-DI: 10889942172122(each)
- 40889942172123(case)
- Lot Number: 2025101090
- 2) PHS234706I
- UDI-DI: 10198459330278(each)
- 40198459330279(case)
- Lot Number: 25JLB029
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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