Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 20, 2019
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.
Potential esophageal laceration during a patient procedure
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
US Endoscopy Group Inc recalled US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is ind… - a moderate-severity action.
US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is ind… was recalled by US Endoscopy Group Inc in March 20, 2019. Reason: Potential esophageal laceration during a patient procedure. Check the official notice for the remedy. Verify recall #Z-1011-2019 with the FDA Devices before acting.
The recall
US Endoscopy Group Inc issued this moderate-severity FDA Devices recall-Potential esophageal laceration during a patient procedure.
- Moderate
- severity level
- 483 units
- affected scope
- Class II
- classification
- March 20, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1011-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1011-2019) was formally reported on March 20, 2019, with the manufacturer initiating the action on February 4, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. US Endoscopy Group Inc is listed as the recalling firm, operating out of Mentor, OH. Federal records list the affected scope as 483 units ( 325 units US and 158 OUS).
The documented reason for this recall is: Potential esophageal laceration during a patient procedure Distribution data in the federal record shows the product reached: 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 …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
483 units ( 325 units US and 158 OUS)
Related Recalls
6
0 from same agency
Product description
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.
Reason for recall
Potential esophageal laceration during a patient procedure
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1011-2019 |
| Date reported | March 20, 2019 |
| Date initiated | February 4, 2019 |
| Recalling firm | US Endoscopy Group Inc |
| Firm location | Mentor, OH |
| Affected scope | 483 units ( 325 units US and 158 OUS) |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1011-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by US Endoscopy Group Inc. Units affected: 483 units ( 325 units US and 158 OUS).
Why was this product recalled? ▼
Potential esophageal laceration during a patient procedure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2019. Severity: Moderate. Recall number: Z-1011-2019.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1011-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 20, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.