Taewoong Medical recalls Niti-S esophageal stents with misprinted instructions that could lead to improper use. Affected models include ES1806F through ES2010B and specific serial numbers. Consumers should check their product details.
Misprinted IFUs shipped with esophageal stents
Taewoong Medical is recalling certain Niti-S esophageal stents due to misprinted instructions that could lead to improper use. This recall affects specific model numbers and serial numbers listed in the notice.
The stents came with incorrect instructions that could lead to improper use. Misprinted instructions might cause the stent to be placed incorrectly, potentially causing complications.
Patients who have received the recalled Niti-S esophageal stents with misprinted instructions. Those who have the listed model numbers or serial numbers are most at risk.
Check if your stent model number matches ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, or other listed models. Also, verify the serial number against the provided list.
Review your stent's model number and serial number to see if they match the listed affected items.
The recall is due to misprinted instructions that could lead to improper use, but the stents themselves are not inherently dangerous. The risk is low if the instructions are followed correctly.
Check your stent's model number and serial number against the list provided in the recall notice.
The recall does not specify a remedy, so contact Taewoong Medical for guidance on next steps.
We’ve drafted a message you can send Taewoong Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1229-2020 — Taewoong Medical Taewoong Medical Hello, I own a Taewoong Medical that is covered by recall Z-1229-2020 from Taewoong Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
