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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
Potential for contamination with cotton fibers.
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Due to distributing the measles IgG IVD without a premarket approved/cleared.
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Potential for contamination with cotton fibers.