All recalls7,877 total
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)
Sub-Potent Drug: Subpotent assay results during stability testing.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Sub-Potent Drug: Subpotent assay results during stability testing.
Failed Dissolution Specifications.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.