Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 553–564 of 801 recalls
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert.…
Potential presence of residual adhesive material on the mesh surface.
Potential presence of residual adhesive material on the mesh surface.
Potential presence of residual adhesive material on the mesh surface.
Potential presence of residual adhesive material on the mesh surface.
Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded.…
The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.