Severity
Moderate
FDA Devices recall · Reported October 10, 2012
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 becom…
US Endoscopy Group Inc recalled Endoscopic retrieval device. The disposable Raptor grasping device in intended to retr… - a moderate-severity action.
Endoscopic retrieval device. The disposable Raptor grasping device in intended to retr… was recalled by US Endoscopy Group Inc in October 10, 2012. Reason: When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the pat…. Check the official notice for the remedy. Verify recall #Z-0006-2013 with the FDA Devices before acting.
The recall
US Endoscopy Group Inc issued this moderate-severity FDA Devices recall-When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the pat….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0006-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0006-2013) was formally reported on October 10, 2012, with the manufacturer initiating the action on November 14, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. US Endoscopy Group Inc is listed as the recalling firm, operating out of Mentor, OH. Federal records list the affected scope as 1153.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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 …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
1153
Related Recalls
6
3 from same agency
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.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0006-2013 |
| Date reported | October 10, 2012 |
| Date initiated | November 14, 2011 |
| Recalling firm | US Endoscopy Group Inc |
| Firm location | Mentor, OH |
| Affected scope | 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 countr… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 10, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.