# FDA recall Z-1011-2019

> **US Endoscopy Group Inc** · Class II · device recall initiated 2019-02-04.

## 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.

## Reason for recall

Potential esophageal laceration during a patient procedure

## 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.

## Key facts

- **Recall number:** Z-1011-2019
- **Recalling firm:** US Endoscopy Group Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-04
- **Report date:** 2019-03-20
- **Termination date:** 2020-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mentor, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1011-2019

## Citation

> AI Analytics. FDA recall Z-1011-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1011-2019. Source: US FDA. Licensed CC0.

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