Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Niti-S Esophageal Stent Recalled by Taewoong Medical Co., Ltd. Due to Misprinted IFUs shipped with esophageal stents
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Taewoong Medical Co., Ltd. directly.
Affected Products
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
Quantity: 178
Why Was This Recalled?
Misprinted IFUs shipped with esophageal stents
Where Was This Sold?
This product was distributed to 1 state: IN
About Taewoong Medical Co., Ltd.
Taewoong Medical Co., Ltd. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report