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Recall Observatory FDA recall evidence

Device product

Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A

Z-2547-2026

May 21, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 99162
Status
Ongoing
Classification
Class II
Quantity
180 kits
Official record key
device-enforcement:Z-2547-2026

Official wording

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. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

Code information: 1) DYNJ57922A, UDI-DI: 10195327556259(each), 40195327556250(case), Lot Number: 25JLA852

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.