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FDA Medical Device Recalls (openFDA)

US Endoscopy Group Inc: Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.

Recall number
Z-1453-2015
Recalling firm
US Endoscopy Group Inc
Product
Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
Status
Terminated
Initiated
2015-03-10
Posted
2015-04-16
Terminated
2016-10-27
Reason
A wire component on the distal grasping assembly of the device became detached..
Root cause
Under Investigation by firm
Action
On 03/25/2015 the firm sent recall notification letters to their customers via email.
Quantity
1695 units
Distribution
Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. Product was also sent to the following countries: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, ESTONIA, FRANCE, MEXICO, NEW ZEALAND, SAUDI ARABIA & SWEDEN.
Lot, serial or model codes
Model #00711175; Lot #'s: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.
510(k) numbers
["K962676"]
PMA numbers
not on file
Product code
OCZ
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

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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

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