Complete FDA and NHTSA recall records dated in December 2023.
These records include useful source details for the selected month.
Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may…
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…
Potentially defective utility trays in the reagent kits.
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.
Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
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
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
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…
Their is a potential that intraocular implant devices may not meet specifications.
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 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.
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
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…
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Their is a potential that intraocular implant devices may not meet specifications.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential…
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…
Their is a potential that intraocular implant devices may not meet specifications.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
