Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 757–768 of 1,125 recalls
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2,…
The products may contain surface and subsurface contamination of Listeria monocytogenes.
The products may contain surface and subsurface contamination of Listeria monocytogenes.
The products may contain surface and subsurface contamination of Listeria monocytogenes.
The products may contain surface and subsurface contamination of Listeria monocytogenes.
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.