All Recalls

95,114 total recalls in our database

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.

Stryker Instruments Div. of Stryker

🏥 Medical Devices Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

Maquet Medical Systems USA

🏥 Medical Devices Class I - Dangerous

Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach.

Apr 16, 2014 Surgical Instruments Nationwide View Details →

Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.

Philips Healthcare

🏥 Medical Devices Class I - Dangerous

If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted.

Mar 5, 2013 Diagnostic Equipment Nationwide View Details →

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.

Stryker Instruments Div. of Stryker

🏥 Medical Devices Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 2.0mm 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.

Stryker Instruments Div. of Stryker

🏥 Medical Devices Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.

Teleflex Medical

🏥 Medical Devices Class I - Dangerous

Several complaints were received for the metal support tube missing from the cholangiogram catheter.

May 16, 2014 Surgical Instruments View Details →

Stryker 3.0mm x 3.8mm Neuro Drill Less 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.

Stryker Instruments Div. of Stryker

🏥 Medical Devices Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 5.0mm Barrel 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.

Stryker Instruments Div. of Stryker

🏥 Medical Devices Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

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.

Stryker Instruments Div. of Stryker

🏥 Medical Devices Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.

Synthes

🏥 Medical Devices Class I - Dangerous

It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.

Apr 22, 2014 Other Medical Devices View Details →

Stryker 0.5mm 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.

Stryker Instruments Div. of Stryker

🏥 Medical Devices Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through magnification and illumination.

Leica Microsystems

🏥 Medical Devices Class I - Dangerous

The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).

Sep 11, 2013 Other Medical Devices View Details →

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.

Stryker Instruments Div. of Stryker

🏥 Medical Devices Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.

BioDerm

🏥 Medical Devices Class I - Dangerous

On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.

May 31, 2011 Surgical Instruments Nationwide View Details →