Class II — Taewoong Medical Co., Ltd.
| Recalling firm | TAEWOONG MEDICAL CO., LTD |
|---|---|
| Registered facility | TAEWOONG MEDICAL CO., LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Misprinted IFUs shipped with esophageal stents |
| Product | Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F |
| Quantity | 178 |
| Distribution | U.S.: IN |
| Initiated | 2019-10-18 |
| Classified | 2020-02-13 |
| Terminated | 2021-10-15 |
| Recall number | Z-1229-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Taewoong Medical Co., Ltd. (Z-1229-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84742/
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