Niti-S Esophageal Stent — Class II medical device recall Z-1229-2020
Terminated recall by Taewoong Medical Co., Ltd., reported 2020-02-19. Misprinted IFUs shipped with esophageal stents
| Recall number | Z-1229-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taewoong Medical Co., Ltd., Gyeonggi-Do, Korea (the Republic of) |
| Recall initiated | 2019-10-18 |
| Classified | 2020-02-13 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2021-10-15 |
| Quantity | 178 |
| Serial numbers | 13F0021C9IE664, 16D5343C9IE881, 16D5429C9IE565, 16D5646C9IE668, 16D5650C9IE672, 16D5894C9IE666, 16D6018C9IE671, 16D6106C9IE663, 16H4826C9IE665, 16K4066C9IE567, 16K4777C9IE566, 16L1621C9IE669, 16L1711C9IE589, 16L1991C9IE673, 16L5518C9IE670, 17H3096C9IE667, 17H3384C9IE568, 18B1255C9IE659, 18E5617C9IE660, 18F1781C9IE661, 18G3000C9IE662, 18K1514C9IE521, 18K3870C9IE677, 18K3871C9IE678, 18K4092C9IE679 and 153 more |
| Model numbers | ES1610F, ES1612B, ES1612F, ES1615B, ES1615F, ES1806F, ES1808F, ES1810B, ES1810F, ES1812B, ES1815B, ES1815F, ES2006B, ES2006F, ES2008F, ES2010B, ES2010F, EST1806F, EST1808F, EST1810F, EST1814F, EST2008F, EST2010F, EST2012B, EST2012F and 1 more |
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
Reason for recall
Misprinted IFUs shipped with esophageal stents
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1229-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.