Mentor, OH, United States
US Endoscopy Group Inc recalls
1 recall recorded since 2018, most recently on 4 February 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 4 February 2019
- Terminated
- 3 August 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1011-2019
- 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 treatin
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.