FDA Device recall Z-1229-2020

Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES…

FDA Device
Class II
terminated
Published 2020-02-19

On 2020-02-19 the FDA classified a Class II recall of Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES… by Taewoong Medical, citing misprinted IFUs shipped with esophageal stents.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1229-2020
Classification	Class II
Status	terminated
Initiated	2019-10-18
Published	2020-02-19
Last updated	2026-09-13 11:55 UTC
Company	Taewoong Medical
Distribution	IN

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

Misprinted IFUs shipped with esophageal stents

Identifiers

code_info	Serial #: 16D5429C9IE565, 16K4777C9IE566, 16K4066C9IE567, 17H3384C9IE568, 16L1711C9IE589, 18K4093C9IE590, 19H495… 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,

code_info

Serial #: 16D5429C9IE565, 16K4777C9IE566, 16K4066C9IE567, 17H3384C9IE568, 16L1711C9IE589, 18K4093C9IE590, 19H495…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1229-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.