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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.

Haemonetics

Class I - Dangerous

Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.

Jan 26, 2015 Other Medical Devices View Details →

Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.

Siemens Medical Solutions USA

Class I - Dangerous

The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

Jan 16, 2015 Diagnostic Equipment Nationwide View Details →

Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.

Pulsion Medical

Class I - Dangerous

Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

Nov 4, 2014 Diagnostic Equipment Nationwide View Details →

Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.

Biomet

Class I - Dangerous

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

Jan 9, 2015 Implants & Prosthetics View Details →

MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.

Nidek

Class I - Dangerous

The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.

Mar 27, 2012 Other Medical Devices Nationwide View Details →

Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.

Cincinnati Sub-Zero Products

Class I - Dangerous

Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.

Jan 7, 2015 Other Medical Devices Nationwide View Details →

Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

Alivecor SFO

Class I - Dangerous

Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.

Jan 9, 2015 Diagnostic Equipment View Details →

Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

Alltech Medical Systems America

Class I - Dangerous

The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

Jan 9, 2015 Diagnostic Equipment View Details →

Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.

Mako Surgical

Class I - Dangerous

When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

Jan 22, 2015 Implants & Prosthetics Nationwide View Details →

BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP

CME America

Class I - Dangerous

CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.

Jan 16, 2015 Infusion Pumps Nationwide View Details →

HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System

Intuitive Surgical

Class I - Dangerous

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

Jan 21, 2015 Surgical Instruments View Details →

MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

Teleflex

Class I - Dangerous

Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.

Dec 4, 2014 Surgical Instruments View Details →

Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Elekta

Class I - Dangerous

Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.

Jan 7, 2015 Other Medical Devices View Details →

Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Synthes

Class I - Dangerous

Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement.

Jan 6, 2012 Implants & Prosthetics View Details →

CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.

Maquet Datascope Corp - Cardiac Assist Division

Class I - Dangerous

Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.

Dec 16, 2014 Infusion Pumps View Details →

LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and the cannot-intubate-cannot-ventilate situation.

Teleflex Medical

Class I - Dangerous

The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff).

Jan 13, 2015 Infusion Pumps Nationwide View Details →

EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.

Natus Medical Incorporated

Class I - Dangerous

Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.

Jan 2, 2015 Other Medical Devices Nationwide View Details →

AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

Teleflex Medical

Class I - Dangerous

The packages may contain foreign material (black particles).

Jan 14, 2015 Other Medical Devices Nationwide View Details →

AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

Teleflex Medical

Class I - Dangerous

The packages may contain foreign material (black particles).

Jan 14, 2015 Other Medical Devices Nationwide View Details →

Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.

Teleflex Medical

Class I - Dangerous

Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.

Jan 9, 2015 Other Medical Devices View Details →