Boston Scientific Corporation - Boston Scientific ORISE Gel Syringe Submucosal Lifting Agent Kits - Class 2 Recall
ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 12, 2022 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Boston Scientific ORISE Gel Submucosal Lifting Agent - Class 2 Recall
ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as follows: UPN: (1)Twin Pack Box 1 M00519200 (2)Twin Pack Box 10 M00519201 (3)Single Pack Box 1 M00519220 (4)Single Pack Box 10 M00519221 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 12, 2022 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Boston ScientificORISE ProKnife Procedure Kits - Class 2 Recall
ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device. UPN (1)ORISE ProKnife 1.5 mm Electrode - Kit M00519380; (2) ORISE ProKnife 2.0 mm Electrode - Kit M00519390; (3) ORISE ProKnife 3.0 mm Electrode - Kit M00519400 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 12, 2022 Category: Medical Devices Source Type: alerts
Diversatek Healthcare - Class 2 Recall
Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 20, 2022 Category: Medical Devices Source Type: alerts
Richard Wolf GmbH - TEM tube set - Class 2 Recall
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 28, 2020 Category: Medical Devices Source Type: alerts
