Medline Ophthalmic Pack with Lidocaine Injection Kits Recalled
Medline is recalling Ophthalmic Pack convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA manufacturing inspection. The recall affects 180 kits 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 text does not report any illnesses, injuries, or hospitalization, and identifies quality issues as the concern without specifying a concrete safety hazard. This meets the criteria for a Moderate severity recall.
Plain-English summary
Medline Industries, LP is recalling Ophthalmic Pack with Lidocaine convenience kits (Model Number DYNJ57922A, Lot Number 25JLA852) distributed nationwide. The kits contain Huons Lidocaine HCL Injection USP 1% 10mg/ml in 5mL ampules.
The recall was initiated because quality issues were identified during a recent FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site. The FDA has classified this as a Class II recall.
Consumers and healthcare providers in possession of affected kits should stop using them immediately. For additional information or to report the product, contact Medline Industries, LP or visit the FDA's website at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2547-2026.
The recalled product
- Product
- Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
- Manufacturer
- Medline Industries, LP
- Category
- Drug — Ophthalmic / Injectable
- Hazard
- Affected units
- 180
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) DYNJ57922A
- UDI-DI: 10195327556259(each)
- 40195327556250(case)
- Lot Number: 25JLA852
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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