Medline Lidocaine HCL Injection Ampules Recalled for Quality Issues
Medline Industries is recalling convenience kits containing Huons Lidocaine HCL Injection USP 1% ampules due to quality issues identified during an FDA manufacturing inspection of the drug maker's site.
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 recall is classified as FDA Class II and involves a quality issue identified during manufacturing inspection. No illnesses or injuries have been reported, and the hazard is preventive rather than confirmed; this meets the threshold for Moderate severity.
Plain-English summary
Medline Industries, LP is recalling multiple convenience kits (967 total) that contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 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 kits were distributed nationwide and include 34 different model numbers of central venous catheter (CVC) insertion bundles and related kits. Specific lot numbers and UDI codes for each model are available through the FDA recall reference number Z-2536-2026.
Patients and healthcare providers who have received these kits should contact Medline Industries or consult the FDA website for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F…
- Manufacturer
- Medline Industries, LP
- Category
- Drug — Injection / Ampule
- Affected units
- 967
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 (20)
- 1) ECVC5995
- UDI-DI: 10653160338970(each)
- 00653160338973(case)
- Lot Number: 2026011990
- 2) ECVC2625
- UDI-DI: 10653160334255(each)
- 00653160334258(case)
- Lot Number: 2025121990
- 3) STCVC26US
- UDI-DI: 10653160343424(each)
- 00653160343427(case)
- Lot Number: 2026010290
- 4) ECVC3720
- UDI-DI: 10653160341499(each)
- 00653160341492(case)
- Lot Number: 2025123090
- 5) 3K16H1838
- UDI-DI: 10653160341260(each)
- 00653160341263(case)
- Lot Number: 2025120590
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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