Medical DeviceFeb 19, 2020
Taewoong Medical Co Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F recall — FDA Z-1229-2020
Misprinted IFUs shipped with esophageal stents
Class IIFDA: TerminatedTaewoong Medical Co., Ltd.
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies Taewoong Medical Co., Ltd. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.