CooperSurgical, Inc. - Cooper Surgical - Class 2 Recall
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 7, 2023 Category: Medical Devices Source Type: alerts
CooperSurgical, Inc. - Cooper Surgical - Class 2 Recall
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 7, 2023 Category: Medical Devices Source Type: alerts
CooperSurgical, Inc. - Cooper Surgical - Class 2 Recall
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-4005 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 7, 2023 Category: Medical Devices Source Type: alerts
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
Aomori Olympus Co., Ltd. - SD400U15 SNAREMASTER PLUS Hot/Cold 15m - Class 2 Recall
SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2021 Category: Medical Devices Source Type: alerts
Aomori Olympus Co., Ltd. - SD400U10 SNAREMASTER PLUS Hot/Cold 10m - Class 2 Recall
SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2021 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
US Endoscopy Group Inc - Roth Net Polyp Retrieval - Class 3 Recall
Roth Net Polyp Retrieval (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 9, 2017 Category: Medical Equipment Source Type: alerts
Laurimed LLC - PolypVac - Class 3 Recall
PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile - Sterilized using electron beam radiation. Packaging: Device is individually packaged in a sterile pouch. Four pouched devices are placed in a chipboard box. The chipboard box is then placed in a corrugated box for shipment to the customer. Manufactured for Laurimed LLC, 500 Arguello St., Redwood City, CA 94063 Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2014 Category: Medical Equipment Source Type: alerts
Boston Scientific Corporation - Boston Scientific Twister PLUS - Class 2 Recall
TWISTER¿ PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2014 Category: Medical Equipment Source Type: alerts
Boston Scientific Corporation - Boston Scientific TWISTER - Class 2 Recall
Boston Scientific TWISTER¿ PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2014 Category: Medical Equipment Source Type: alerts
Boston Scientific Corporation - Boston Scientific PLUS - Class 2 Recall
Boston Scientific¿ PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2014 Category: Medical Equipment Source Type: alerts
