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

Class I - Dangerous

🏥 Medical Devices Recalled: October 18, 2019 Taewoong Medical Co. Implants & Prosthetics

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Taewoong Medical Co., Ltd.
Reason for Recall:: Misprinted IFUs shipped with esophageal stents
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot 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

Distribution:

Distributed in: IN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1229-2020