GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.
All Recalls
95,018 total recalls in our database
Medtronic SynchroMed, Model A10
Medtronic
🏥 Medical Devices Class I - Dangerous
The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Bebig Isotopentechnik Gmbh
🏥 Medical Devices Class I - Dangerous
Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
STERILE PVP SLN KIT, REF DYNDM1097
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
🏥 Medical Devices Class I - Dangerous
Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.
🏥 Medical Devices Class I - Dangerous
BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
Ortho-Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Meridian Bioscience
🏥 Medical Devices Class I - Dangerous
Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Ortho-Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
🏥 Medical Devices Class I - Dangerous
Incorrect product labeling. Exterior product box label does not match internal pouch label.
PVP SOLUTION SING STRL, REF DYNDA1858
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Can-Am® Commander series, Defender series, Maverick Trail series equipped with an HD7 or 700 engines side-by-side vehicles (Model Year 2022 and 2023)
BRP Mexico, of Mexico
🏠 Consumer Products Class II - Moderate
The operator's guide maintenance schedule section contains incorrect information regarding proper maintenance intervals for the clutch which can lead to clutch failure, including fragments to be ejected from the vehicle if not serviced, posing a risk of serious injuries.
PowerXL™ DUAF-10 and DUAF-005 Vortex Dual-Basket Air Fryers
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The plastic U-Channel connector used to optionally combine the two food baskets inside of the air fryers can break during use, posing a burn hazard.
Utility Vehicles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
Components of the steering shaft/steering system could have been improperly assembled which can lead to loss of control, posing crash and collision hazards.
Model Year 2023-2024 Ranger XP Kinetic Recreational Off-Road Vehicles (ROVs)
Polaris Industries Inc., of Medina, Minnesota
🏠 Consumer Products Class I - Dangerous
Pressing the brake and throttle pedals simultaneously can deactivate the throttle. If the brake is then released, the vehicle can move and the throttle can still be deactivated, posing a crash hazard and risk of serious injury.
Model Year 2021-2024 RZR 200 Youth ROVs
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The steering system can lock up while in use, posing a crash hazard and risk of serious injury to children.
Room & Board Griffin Duo Bunk Beds
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
Some Griffin Duo Bunk Beds failed to be properly assembled by Room & Board with set screws installed into the side rail brackets at the time of delivery. Brackets lacking set screws can create a collapse risk, and fall and injury hazards.
Savvy Rest Quilted Cotton Mattress Pads
Savvy Rest Inc., of Charlottesville, Virginia
🏠 Consumer Products Class I - Dangerous
The recalled quilted cotton mattress pads fail to meet the mandatory federal flammability standard for mattress pads, posing a fire hazard.
Traeger Flatrock Flat Top Propane Grills
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The burner control knob can be incorrectly labeled, which can result in the grill being unintentionally left on, posing a fire hazard.