Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
IceSeed" Prostate Cryoablation Kit
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
🏥 Medical Devices Class I - Dangerous
There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.
Three IcePearl" 2.1 CX Prostate Cryoablation Kit
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
🏥 Medical Devices Class I - Dangerous
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
GA HEALTH COMPANY LIMITED
🏥 Medical Devices Class I - Dangerous
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
GA HEALTH COMPANY LIMITED
🏥 Medical Devices Class I - Dangerous
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
IcePearl" 2.1 CX L 90¿ Cryoablation Needle
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
IceRod" 1.5 MRI Cryoablation Needle¿
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
There is a potential software error during programming.
IceFORCE" 2.1 CX Prostate Cryoablation Kit
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Complaint trend regarding needle shaft gas leaks.
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
🏥 Medical Devices Class I - Dangerous
The product is mislabeled.
🏥 Medical Devices Class I - Dangerous
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.