Z-0006-2013Class II

Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or...

Name: Z-0006-2013 Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or...
Creator: US Endoscopy Group Inc
Published: 2011-11-14
License: https://open.fda.gov/license/

United States Endoscopy Group, Inc. / initiated 2011-11-14 / Terminated / root cause: design

FDA source

US Endoscopy Group Inc began a recall of Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures... on 2011-11-14. FDA classified it as Class II and gives the reason as "When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0006-2013
Classification: Class II
Status: Terminated
Initiated: 2011-11-14
Posted: 2012-10-03
Terminated: 2013-07-02
Recalling firm: United States Endoscopy Group, Inc.
Product: Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Product code: FGO Dislodger, Stone, Flexible
Reason for recall: When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.
Root cause tag: design
FDA root cause: Device Design
Action: US Endoscopy initiated a Voluntary Product Recall letter initiated November 11, 2011. The letter identified the product the problem and the action needed to be taken by the customer. US Endoscopy will provide a free replacement or grant your facility a credit toward a future purchase for every device that is returned to US Endoscopy or verified as having been used or destroyed. For further questions please call 440-639-4494 ext. 378.
Quantity in commerce: 1153
Distribution: Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI; and to the following countries: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Caribbean, Chile, Columbia, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, India, Ireland, Israel, Italy, Jordan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, and United Arab Emirates.
Product codes and lots: Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0006-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0006-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-10-03

Product code FGO

K962676Class IIDisposable Endoscopic Retrieval DeviceUnited States Endoscopy Group, Inc. / cleared 1996-10-04

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)