Manufacturer

US Endoscopy Group Inc

10 recalls in our database name US Endoscopy Group Inc as the manufacturing or recalling firm.

What the numbers show

Total: 10
Critical: 0
Severe: 0
Most recent: 2019-03-20

Of the 10 recalls from US Endoscopy Group Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

HighFDA (Devices)·Z-1011-2019·2019-03-20
US Endoscopy Padlock Clip Recalled for Potential Esophageal Laceration Risk
US Endoscopy Group Inc is recalling Padlock Clip defect closure systems due to a risk of esophageal laceration during patient procedures.
Product
US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1416-2017·2017-03-15
US Endoscopy Recalls Roth Net Polyp Retrieval Due to Date Mismatch
US Endoscopy Group Inc is recalling Roth Net Polyp Retrieval devices because the expiration date on the outer carton is shorter than the date on the inner package.
Product
Roth Net Polyp Retrieval
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0289-2017·2016-10-26
US Endoscopy Recalls Vari-Safe Injection Needles Due to Incorrect Distribution
US Endoscopy is voluntarily recalling one lot of Vari-Safe Injection Needles because the lot was incorrectly distributed with different internal catheter components.
Product
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0001-2016·2015-10-07
US Endoscopy Recalls Histolock Resection Device Due to Sterility Concerns
US Endoscopy Group Inc is recalling 41 units of the Histolock Resection Device because the company cannot assure the sterility of the affected lot.
Product
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1943-2015·2015-07-08
US Endoscopy Recalls Velocity Biopsy Valves Due to Structural Defect
US Endoscopy Group Inc is recalling Velocity Biopsy Valves because the valve body and irrigation tube may separate during use.
Product
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1453-2015·2015-04-22
US Endoscopy Recalls Talon Grasping Devices Due to Detached Wire Component
US Endoscopy Group Inc is recalling 1,695 Talon Grasping Devices because a wire component on the distal grasping assembly became detached.
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.
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-0861-2015·2014-12-31
US Endoscopy Recalls UroSeal Valves Due to Sterile Seal Integrity Issues
US Endoscopy Group Inc is recalling 100 units of UroSeal Adjustable Endoscopic Valves because the sterile pouch seals may not be intact.
Product
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1099-2013·2013-04-17
US Endoscopy Recalls Torrent Irrigation Tubing Due to Water Leakage
US Endoscopy Group Inc is recalling Torrent irrigation tubing because customers reported water leakage from the white tubing connector.
Product
Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic proc
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0006-2013·2012-10-10
US Endoscopy Raptor Grasping Device Recalled for Potential Jaw Failure
US Endoscopy Group Inc is recalling 1,153 Raptor grasping devices because the jaws may become stuck open if excessive force is applied while the catheter is coiled.
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2396-2012·2012-09-26
US Endoscopy Recalls Infinity Cytology Brushes Due to Deployment Issues
US Endoscopy is recalling 393 Infinity sampling devices because the cytology brush may be difficult to deploy through the catheter.
Product
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
Category
Medical Device
Distribution
19 states