US Endoscopy Padlock Clip Recalled for Potential Esophageal Laceration Risk
US Endoscopy Group Inc is recalling Padlock Clip defect closure systems due to a risk of esophageal laceration during patient procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (esophageal laceration) where specific injury counts are not reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported or is not quantified in the source.
Plain-English summary
US Endoscopy Group Inc is recalling the Padlock Clip defect closure system (Ref: C910001). This medical device is indicated for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract, for hemostasis, or for treating lesions of the wall of the gastrointestinal organs.
The recall is issued because of a potential risk of esophageal laceration during a patient procedure. The source text does not specify the exact mechanical defect or the number of reported injuries.
A total of 483 units are affected, comprising 325 units distributed in the United States and 158 units distributed outside the United States. The affected lots are 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177. Distribution was worldwide, including the US, Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden, and the United Arab Emirates.
The recalled product
- Product
- US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
- Manufacturer
- US Endoscopy Group Inc
- Category
- Medical Device — Endoscopy
- Hazard
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 (14)
- Lot Numbers: 1814568
- 1814569
- 1815200
- 1815592
- 1816056
- 1817174
- 1817810
- 1818187
- 1818596
- 1819180
- 1819181
- 1819407
- 1819793
- and 1820177.
Distribution
Distributed nationwide across the United States.
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