FDA Medical Device Recalls (openFDA)
US Endoscopy Group Inc: 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.
- Recall number
- Z-1011-2019
- Recalling firm
- US Endoscopy Group Inc
- 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.
- Status
- Terminated
- Initiated
- 2019-02-04
- Posted
- not on file
- Terminated
- 2020-08-03
- Reason
- Potential esophageal laceration during a patient procedure
- Root cause
- Device Design
- Action
- The firm, US Endoscopy issued a Recall Notification Letter entitled "URGENT VOLUNTARY RECALL NOTICE" and dated 2/1/19 on 2/4/19 to Customers who purchased affected lots of the Padlock Defect closure system. The Recall Notification Letter was sent to domestic Customers via FedEx with delivery confirmation receipt. Affected international distributors issued Recall Notification Letter via email. Letter identifies the product, problem, and actions to take. The customer were instructed to do the following: 1. Quarantine affected Padlock Clip defect closure systems (C910001 ). 2. Complete the Medical Device Recall Response Card included with this Customer Notification Letter. Your US Endoscopy Product Specialist can assist should you have any questions while completing the Card. 3. Return the completed Medical Device Recall Response Card via email to: orders@usendoscopy.com or via fax to 440-639-4495. If you have any questions regarding this matter, please call: 440-392-7633.
- Quantity
- 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.
- Lot, serial or model codes
- Lot Numbers: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.
- 510(k) numbers
- ["K120814"]
- PMA numbers
- not on file
- Product code
- PKL
- Firm FEI
- 1000122656
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28