Taewoong Medical Co., Ltd. 14 Gojeong-ro, Wolgot-Myeon, Gimpo-Si, Gyeonggi-Do Korea (the Republic of) 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Taewoong Medical Co., Ltd. 14 Gojeong-ro, Wolgot-Myeon, Gimpo-Si, Gyeonggi-Do Korea (the Republic of)
Lot Codes / Batch Numbers
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
Products Sold
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
Taewoong Medical Co., Ltd. 14 Gojeong-ro, Wolgot-Myeon, Gimpo-Si, Gyeonggi-Do Korea (the Republic of) is recalling Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, due to Misprinted IFUs shipped with esophageal stents. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Misprinted IFUs shipped with esophageal stents
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026