Z-1416-2017Class III

Roth Net Polyp Retrieval

Name: Z-1416-2017 Roth Net Polyp Retrieval
Creator: US Endoscopy Group Inc
Published: 2016-12-13
License: https://open.fda.gov/license/

United States Endoscopy Group, Inc. / initiated 2016-12-13 / Terminated / root cause: labeling and UDI

FDA source

US Endoscopy Group Inc began a recall of Roth Net Polyp Retrieval on 2016-12-13. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1416-2017
Classification: Class III
Status: Terminated
Initiated: 2016-12-13
Posted: 2017-03-08
Terminated: 2017-06-13
Recalling firm: United States Endoscopy Group, Inc.
Product: Roth Net Polyp Retrieval
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1416-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1416-2017	Class III	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-08

Product code GCJ

K122462Class IIRoth Net RetrieverUnited States Endoscopy Group, Inc. / cleared 2012-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)