Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Summary
The FDA issued a Class II for Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A by Medline Industries, LP. Reason: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. f.
Details
Source
Device Recall
External ID
Z-2547-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Lot/Code Info: 1) DYNJ57922A, UDI-DI: 10195327556259(each), 40195327556250(case), Lot Number: 25JLA852
Quantity Affected: 180 kits
Reason for Recall
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-21
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Medline Industries, LP has 487 FDA actions in our database, including 459 recalls and 28 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 487 FDA actions in our database, including 459 recalls and 28 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2547-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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