Taewoong Esophageal Stents Recalled Due to Misprinted Instructions for Use
Taewoong Medical Co., Ltd. is recalling 178 esophageal stents because the Instructions for Use (IFUs) shipped with the devices were misprinted.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a documentation issue (misprinted IFUs) with no reported injuries or illnesses, fitting the criteria for a Low severity score (documentation issues).
Plain-English summary
Taewoong Medical Co., Ltd. is recalling 178 units of Niti-S Esophageal Stents and Esophageal TTS Stents. The recall is due to misprinted Instructions for Use (IFUs) that were shipped with the devices.
The affected products include various reference numbers for Niti-S Esophageal Stents (e.g., ES1806F, ES1808F) and Esophageal TTS Stents (e.g., EST1806F, EST2012F). The distribution pattern is listed as U.S.: IN.
Consumers and healthcare providers should check their inventory for the specific serial numbers listed in the official recall notice. If a device is found, it should be removed from use and returned to the manufacturer or the distributor from whom it was purchased.
The recalled product
- 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…
- Manufacturer
- Taewoong Medical Co., Ltd.
- Hazard
- Affected units
- 178
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial #: 16D5429C9IE565
- 16K4777C9IE566
- 16K4066C9IE567
- 17H3384C9IE568
- 16L1711C9IE589
- 18K4093C9IE590
- 19H4952C9IE515
- 19F2183C9IE516
- 19H4108C9IE517
- 19H2616C9IE518
- 19H3454C9IE519
- 19F2181C9IE520
- 18K1514C9IE521
- 19F2182C9IE522
- 19H4107C9IE523
- 19F0992C9IE524
- 18K4123C9IE525
- 19E5708C9IE526
- 19E5232C9IE527
- 19F4232C9IE528
Distribution
Distributed in 1 state:
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