All recalls8,508 total
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Foreign material (plastic pieces)
Foreign material (plastic pieces)
Foreign material (plastic pieces)
Foreign material (plastic pieces)
Foreign material (plastic pieces)
Foreign material (plastic pieces)
Foreign material (plastic pieces)
Foreign material (plastic pieces)
Foreign material (plastic pieces)
Foreign material (plastic)
Foreign material (plastic pieces)
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Laryngoscope handles may not illuminate as intended.
Laryngoscope handles may not illuminate as intended.
Laryngoscope handles may not illuminate as intended.
Laryngoscope handles may not illuminate as intended.
The products may contain surface and subsurface contamination of Listeria monocytogenes.
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Laryngoscope handles may not illuminate as intended.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Laryngoscope handles may not illuminate as intended.
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Undeclare Tree Nuts (almond, macadamia nut)
Pecans have the potential to be contaminated with Salmonella,
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations; particulates identified during visual inspection
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Potential for the manometer port being blocked rendering the manometer non-functional.
Knee implants contain incorrect labeling (size and/or side incorrect)
Knee implants contain incorrect labeling (size and/or side incorrect)