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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Stimwave Technologies

Class I - Dangerous

The product contains a non-functional component not referenced in product labeling.

Jul 15, 2020 Other Medical Devices Nationwide View Details →

Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes.

Remel Europe

Class I - Dangerous

Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3

Jul 23, 2020 Diagnostic Equipment Nationwide View Details →

Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

Siemens Medical Solutions USA

Class I - Dangerous

The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost

Jul 24, 2020 Diagnostic Equipment Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Stimwave Technologies

Class I - Dangerous

The product contains a non-functional component not referenced in product labeling.

Jul 15, 2020 Other Medical Devices Nationwide View Details →

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Stimwave Technologies

Class I - Dangerous

The product contains a non-functional component not referenced in product labeling.

Jul 15, 2020 Other Medical Devices Nationwide View Details →

BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.

CareFusion 303

Class I - Dangerous

Infusion pump component defect may result in interruption of patient monitoring

Aug 4, 2020 Diagnostic Equipment Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Stimwave Technologies

Class I - Dangerous

The product contains a non-functional component not referenced in product labeling.

Jul 15, 2020 Other Medical Devices Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →