US Endoscopy recalls Padlock Clip defect closure system (Ref: C910001) due to potential esophageal laceration during patient procedures. Affected units include specific lot numbers listed in the recall notice.
Potential esophageal laceration during a patient procedure
US Endoscopy is recalling its Padlock Clip defect closure system (Ref: C910001) because it may cause esophageal lacerations during medical procedures. This is a serious risk that requires immediate action to prevent injury.
The Padlock Clip may cause tears in the esophagus during medical procedures if it fails to close properly. This defect occurs when the clip is used to compress tissue in the gastrointestinal tract, potentially leading to serious injury.
Medical professionals using the Padlock Clip for flexible endoscopy procedures are affected. Patients undergoing procedures with this device are at risk of esophageal laceration.
Check the lot numbers listed: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177. The device is used in flexible endoscopy for gastrointestinal procedures.
Immediately stop using the Padlock Clip if it has the listed lot numbers as it poses a risk of esophageal laceration.
The recall states the Padlock Clip may cause esophageal laceration during procedures, but does not specify the exact defect mechanism.
Affected lot numbers include 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.
The recall does not mention any remedy or replacement options.
We’ve drafted a message you can send US Endoscopy to request your refund or repair — edit it as you like.
Subject: Recall Z-1011-2019 — US Endoscopy US Endoscopy Hello, I own a US Endoscopy that is covered by recall Z-1011-2019 from US Endoscopy. 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.
