Covidien Llc - Beacon EUS Access System Preloaded Access 90 Needle - Class 2 Recall
Beacon EUS Access System Preloaded Access 90¿ Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2020 Category: Medical Devices Source Type: alerts
Capso Vision, Inc. - The CapsoCam Plus - Class 2 Recall
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 8, 2020 Category: Medical Devices Source Type: alerts
Agfa N.V. - DR 800 with MUSICA Dynamic - Class 2 Recall
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 4, 2020 Category: Medical Devices Source Type: alerts
Capso Vision, Inc. - CapsoCam Plus (SV3) - Class 2 Recall
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2020 Category: Medical Devices Source Type: alerts
Avanos Medical, Inc. - CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit - Class 2 Recall
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2020 Category: Medical Devices Source Type: alerts
BioFire Diagnostics, LLC - FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch - Class 2 Recall
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Luminos dRF Max - Class 2 Recall
Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Luminos Agile Max - Class 2 Recall
Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Luminos dRF Max - Class 2 Recall
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Luminos Agile Max - Class 2 Recall
Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2020 Category: Medical Devices Source Type: alerts
Avanos Medical, Inc. - CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kit - Class 2 Recall
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2019 Category: Medical Devices Source Type: alerts
Avanos Medical, Inc. - CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kit - Class 2 Recall
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2019 Category: Medical Devices Source Type: alerts
GASTROGRAFIN (Diatrizoate Meglumine And Diatrizoate Sodium) Liquid [Bracco Diagnostics Inc]
Updated Date: Wed, 09 Oct 2019 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 9, 2019 Category: Drugs & Pharmacology Source Type: alerts
Stryker GmbH - Endotrig, Endotrac and Endintrack Blade Kits - Class 2 Recall
Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2019 Category: Medical Devices Source Type: alerts
Stryker GmbH - Endotrig, Endotrac and Endintrack Blade Kits - Class 2 Recall
Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2019 Category: Medical Devices Source Type: alerts
