Us Endoscopy Group recalls
Us Endoscopy Group appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2019-03-20.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 10 |
|---|---|
| Published | 2012-09-26 to 2019-03-20 |
| By agency | FDA Device (10) |
| By classification | Class II (9), Class III (1) |
| By status | terminated (10) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compre…
FDA Device · Class II · 2019-03-20 · Us Endoscopy Group
Reason: Potential esophageal laceration during a patient procedure - Roth Net Polyp Retrieval
FDA Device · Class III · 2017-03-15 · Us Endoscopy Group
Reason: 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. - Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be u…
FDA Device · Class II · 2016-10-26 · Us Endoscopy Group
Reason: US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components w… - Histolock Resection Device, US Endoscopy
FDA Device · Class II · 2015-10-07 · Us Endoscopy Group
Reason: The company has determined the sterility cannot be assured for the affected lot. - Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy in…
FDA Device · Class II · 2015-07-08 · Us Endoscopy Group
Reason: The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use. - Talon Grasping Device, 160 cm, US endoscopy
FDA Device · Class II · 2015-04-22 · Us Endoscopy Group
Reason: A wire component on the distal grasping assembly of the device became detached.. - UroSeal Adjustable Endoscopic Valve
FDA Device · Class II · 2014-12-31 · Us Endoscopy Group
Reason: Packaging non-conformance related to the integrity of the sterile pouch seal. - Torrent" irrigation tubing
FDA Device · Class II · 2013-04-17 · Us Endoscopy Group
Reason: The firm was notified by their customers that there was a water leakage from the white tubing connector. - Endoscopic retrieval device
FDA Device · Class II · 2012-10-10 · Us Endoscopy Group
Reason: 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… - Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling d…
FDA Device · Class II · 2012-09-26 · Us Endoscopy Group
Reason: US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.