Lutronic Corporation
Medical device establishment · Goyang, Korea (the Republic of)
Lutronic Corporation, based in Goyang, Korea (the Republic of), has 1 FDA recall on file.
FDA record
Recent FDA actions
Questions about Lutronic Corporation
No warning letter naming Lutronic Corporation is on file. FDA has published 1 recall naming it.
Yes. FDA's enforcement reports list 1 recall by Lutronic Corporation; the latest, reported on 2026-09-16, is a Class II recall.
Lutronic Corporation is based in Goyang, Korea (the Republic of). The address is the one on its FDA records, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Lutronic Corporation; every record links to the source, and nothing here is advice.
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