Widex A/S - WIDEX BABY440 - Class 2 Recall
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 11, 2018 Category: Medical Devices Source Type: alerts

Cochlear Americas Inc. - Cochlear Nucleus Sterile Silicone Template - Class 2 Recall
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2015 Category: Medical Equipment Source Type: alerts

AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL (Carbamide Peroxide) Liquid [Oaktree Products Inc.]
Updated Date: Dec 16, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - December 16, 2014 Category: Drugs & Pharmacology Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 1.5mm Wire Pass Drill - Class 2 Recall
Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 6.0mm Acorn Bur - Class 2 Recall
Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 5.0mm Acorn Bur - Class 2 Recall
Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 5.5mm Round Fluted Bur Aggressive - Class 2 Recall
Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 1.3mm Wire Pass Drill - Class 2 Recall
Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 3.0mm Round Fluted Bur Aggressive - Class 2 Recall
Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 6.0mm Zyphr Elite Round Fluted Bur - Class 2 Recall
Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 1.0mm Round Fluted Bur - Class 2 Recall
Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch - Class 2 Recall
Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 3.0mm x 3.8mm Neuro Drill - Class 2 Recall
Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 5.0mm Round Fluted Bur Aggressive - Class 2 Recall
Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker 4.5mm Round Fluted Bur Aggressive - Class 2 Recall
Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts