FDA Medical Device Recalls (openFDA)
US Endoscopy Group Inc: Roth Net Polyp Retrieval
- Recall number
- Z-1416-2017
- Recalling firm
- US Endoscopy Group Inc
- Product
- Roth Net Polyp Retrieval
- Status
- Terminated
- Initiated
- 2016-12-13
- Posted
- 2017-03-08
- Terminated
- 2017-06-13
- Reason
- The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.
- Root cause
- Labeling mix-ups
- Action
- US Endoscopy Group sent an Urgent: Roth Net Polyp Retriever Recall letter dated January 6, 2017, to all affected customers. The firm requested their customers to do the following: 1. Quarantine and destroy the affected Roth Net devices in your inventory. 2. Contact US Endoscopy Customer Service at 1-800-769-8226 to obtain no cost replacement product. 3. Complete and return the attached Response Card. For further information please call (440) 358-6055.
- Quantity
- 2,131 units
- Distribution
- US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland & Sweden.
- Lot, serial or model codes
- Model # 0071151; Lot #s: 1613898, Exp. Date October 5, 2019; Lot # 1616337, Exp. Date October 7, 2019; Lot # 1616733, Exp. Date October 7, 2019; Lot # 1616734, Exp. Date October 20, 2019 & Lot # 1616735, Exp. Date October 28, 2019.
- 510(k) numbers
- ["K122462"]
- PMA numbers
- not on file
- Product code
- GCJ
- 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