Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,429–1,440 of 2,908 recalls
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap.…
Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to…
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.
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Potential for temporary loss of imaging (X-ray) functionality due to software issue.