Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the…
Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.
Due to incorrect product/device within packaging.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or…
Their is a potential that intraocular implant devices may not meet specifications.
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Their is a potential that intraocular implant devices may not meet specifications.
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the…
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or…
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm…
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm…
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of…
Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes,…
The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or…
Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability…
Browse recent months with enough recall history for useful comparison.
