Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 433–444 of 822 recalls
Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
Potential for a weak seal in some units resulting in compromise in sterility.
Potential for contamination with cotton fibers.
Potential for contamination with cotton fibers.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.