Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IIFoley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IIFoley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IIFoley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IIFoley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IIFoley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IIFoley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IIFoley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IIFoley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IIFoley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-26FDA-DeviceDegania Silicone, Ltd.Class IITemperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 15 mm x 360 mm, Item Number: 814615360
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 13 mm x 460 mm, Item Number: 814613460
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 13 mm x 440 mm, Item Number: 814613440
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm, Item Number: 814613380
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 13 mm x 360 mm, Item Number: 814613360
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-19FDA-DeviceZimmer Biomet, Inc.Class IIAffixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300
The set screw is not able to advance or reverse from the original position in the nail.
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