CLASS II Device recall · Reported 20 Mar 2019 · FDA Enforcement Report
US Endoscopy Padlock Clip defect closure system recalled
US Endoscopy Group is recalling US Endoscopy Padlock Clip defect closure system, distributed nationwide in the US. The recall was initiated on 4 Feb 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1011-2019
- FDA event ID
- 82142
- Recalling firm
- US Endoscopy Group, Mentor, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2019
- FDA classified
- 13 Mar 2019
- Reported
- 20 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 4 Feb 2019 | Recall initiated by company | |
| 13 Mar 2019 | Classified by FDA | +37 days |
| 20 Mar 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential esophageal laceration during a patient procedure
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.
Questions about this recall
Is US Endoscopy Padlock Clip defect closure system recalled?
Yes. US Endoscopy Group recalled US Endoscopy Padlock Clip defect closure system on 4 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-1011-2019.
Why was it recalled?
Potential esophageal laceration during a patient procedure
Which lots are affected?
Lot Numbers: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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