🏥 Medical Devices Class I - Dangerous
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
All Recalls
95,025 total recalls in our database
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
🏥 Medical Devices Class I - Dangerous
Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert feature(button) removed
Centricity Cardiology CA1000
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
🏥 Medical Devices Class I - Dangerous
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Centricity PACS RA1000
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
V8 Immunodisplacement Kit REF 1803
Helena Laboratories
🏥 Medical Devices Class I - Dangerous
Due to microbial growth causing interference with interpretation.
🏥 Medical Devices Class I - Dangerous
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
🏥 Medical Devices Class I - Dangerous
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
NeuMoDx Molecular
🏥 Medical Devices Class I - Dangerous
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Northgate Technologies
🏥 Medical Devices Class I - Dangerous
Product labeled incorrectly.
🏥 Medical Devices Class I - Dangerous
The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
🏥 Medical Devices Class I - Dangerous
Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
🏥 Medical Devices Class I - Dangerous
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
Brompton Electric Folding Bicycles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The mudguard is positioned too close to the front wheel which can cause the wheel to lock up leading to sudden deceleration of the bike if an object gets caught between the mudguard and front tire, posing crash and injury hazards to the rider.
Hisense French Door Refrigerators with Ice Maker
Hisense USA, of Suwanee, Georgia
🏠 Consumer Products Class II - Moderate
The refrigerator's door hinge can break causing the door to detach when the consumer tries to open the French doors, posing an impact injury hazard to the consumer.
Intimidator and Mahindra branded utility vehicles (UTVs)
Intimidator, of Batesville, Ark.
🏠 Consumer Products Class II - Moderate
The throttle cable can freeze at low ambient temperatures, resulting in a stuck throttle which can cause the brakes to fail to stop the vehicle, posing a crash hazard. Additionally, on certain Model Year 2022 Intimidator GC1K vehicles, the onboard software does not prevent consumers from exceeding 15 mph when the seatbelt is disengaged, posing a crash hazard.
Jungle Jumparoo Children's Toys
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The toys' yellow poles contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.