RecallRadar

FDA Device recall Z-2547-2026

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

On 2026-07-08 the FDA classified a Class II recall of Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A by Medline Industries, citing 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 q….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2547-2026
ClassificationClass II
Statusongoing
Initiated2026-05-21
Published2026-07-08
Last updated2026-09-13 11:58 UTC
CompanyMedline Industries
DistributionUS

Product

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

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.

Identifiers

code_info1) DYNJ57922A, UDI-DI: 10195327556259(each), 40195327556250(case), Lot Number: 25JLA852

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2547-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.