Taewoong Medical Co., Ltd.: 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

Recall number

Z-1229-2020

Recalling firm

Taewoong Medical Co., Ltd.

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

Status

Terminated

Initiated

2019-10-18

Posted

not on file

Terminated

2021-10-15

Reason

Misprinted IFUs shipped with esophageal stents

Root cause

Error in labeling

Action

On 10/18/19, an Esophageal Stent Device Return notices were emailed to the U.S. distributor who was asked to stop releasing products. The distributor was further asked to do the following for products already distributed: please send customers a notification to stop using the product immediately and to return affected product. Then the distributor was asked to return all affected products in their possession including returned products to the manufacturer. e-mail contact: bclee@stent.net

Quantity

178

Distribution

U.S.: IN

Lot, serial or model codes

Serial #: 16D5429C9IE565, 16K4777C9IE566, 16K4066C9IE567, 17H3384C9IE568, 16L1711C9IE589, 18K4093C9IE590, 19H4952C9IE515, 19F2183C9IE516, 19H4108C9IE517, 19H2616C9IE518, 19H3454C9IE519, 19F2181C9IE520, 18K1514C9IE521, 19F2182C9IE522, 19H4107C9IE523, 19F0992C9IE524, 18K4123C9IE525, 19E5708C9IE526, 19E5232C9IE527, 19F4232C9IE528, 19H2615C9IE529, 19H3455C9IE530, 19H4897C9IE531, 19B4591C9IE532, 19H3052C9IE533, 19A5788C9IE534, 19C7871C9IE535, 19D7958C9IE536, 19F5937C9IE537, 19G0615C9IE538, 19G1204C9IE539, 19G2208C9IE540,  19G3296C9IE541, 19G3421C9IE542, 19G3422C9IE543, 19G4536C9IE544, 19G4537C9IE545,  19G4558C9IE546,  19G4559C9IE547,  19G4952C9IE548, 19G5440C9IE549, 19G6408C9IE550, 19G7534C9IE551, 19G7535C9IE552, 19H3453C9IE553, 19H4278C9IE554, 19H4279C9IE555, 19H4576C9IE556, 19H4852C9IE557, 19H4979C9IE558, 19H4980C9IE559, 19H1215C9IE560, 19H4088C9IE561, 19H4577C9IE562, 19H4629C9IE563, 19H4851C9IE564, 19D7674C9IE569, 19E0233C9IE570, 19E2071C9IE571, 19E3052C9IE572, 19E3225C9IE573, 19F1089C9IE574, 19F2200C9IE575, 19F2671C9IE576, 19F3104C9IE577, 19F3918C9IE578, 19G1847C9IE579, 19G2531C9IE580, 19G3645C9IE581, 19G4535C9IE582, 19G5986C9IE583, 19G7857C9IE584, 19H4280C9IE585, 19H4977C9IE586, 19H4978C9IE587, 19H5135C9IE588, 16D6106C9IE663, 13F0021C9IE664, 16H4826C9IE665, 16D5894C9IE666, 17H3096C9IE667, 16L1621C9IE669, 16L5518C9IE670, 16D6018C9IE671, 16D5650C9IE672, 16L1991C9IE673, 19B4446C9IE674, 19B4688C9IE675, 19B4986C9IE676, 18K3870C9IE677, 18K3871C9IE678, 18K4092C9IE679, 16D5646C9IE668, 19G4709C9IE614, 19H3229C9IE615, 19F2792C9IE616, 19G5683C9IE617, 19H5127C9IE618, 19H1069C9IE619, 19G7575C9IE620, 19G3288C9IE621, 19G4825C9IE622, 19H5594C9IE623, 19G5931C9IE624, 19H1879C9IE625, 19H3228C9IE626, 19H3411C9IE627, 19G7011C9IE628, 19H5561C9IE629, 19H1821C9IE630, 19H6164C9IE631, 19G7183C9IE632, 19H5126C9IE633, 19G6820C9IE634, 19G7770C9IE635, 19H1313C9IE636, 19G4710C9IE637, 19H3410C9IE638, 19E7223C9IE639, 19E7681C9IE640, 19E7683C9IE641, 19F0124C9IE642, 19F0125C9IE643, 19F1681C9IE644, 19F3419C9IE645, 19F5330C9IE646, 19F6909C9IE647, 19H2571C9IE648, 19H2617C9IE649, 19H2618C9IE650, 19H3133C9IE651, 19H3134C9IE652, 19H3194C9IE653, 19H3195C9IE654, 19H4838C9IE655, 19H4839C9IE656, 19H5434C9IE657, 19H5435C9IE658, 18B1255C9IE659, 18E5617C9IE660, 18F1781C9IE661, 18G3000C9IE662, 19C5822C9IE680, 19F0295C9IE681, 19F1376C9IE682, 19F2066C9IE683, 19F2165C9IE684, 19F2744C9IE685, 19F2993C9IE686, 19F3375C9IE687, 19F3533C9IE688, 19F4913C9IE689, 19F4964C9IE690, 19F5200C9IE691, 19F5203C9IE692, 19G1871C9IE693, 19G3427C9IE694, 16D5343C9IE881, 19F4265C9IE861, 19H1168C9IE862, 19F1979C9IE863, 19F4530C9IE864, 19H1167C9IE865, 19G4646C9IE866, 19G6005C9IE867, 19G2290C9IE868, 19H1330C9IE869, 19G7319C9IE870, 19G5686C9IE871, 19F4442C9IE872, 19H0088C9IE873, 19F3924C9IE874, 19H5212C9IE875, 19G7395C9IE876, 19G7497C9IE877, 19G4517C9IE878, 19F4443C9IE879, 19G3952C9IE880

510(k) numbers

["K080782","K113551","K123205"]

PMA numbers

not on file

Product code

ESW

Firm FEI

3003902943

Firm city

not on file

Firm state

not on file

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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