Medical Devices Recalls

Hazard: 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.

Hazard: 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.

Hazard: 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. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.

Hazard: 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 sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.

Hazard: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

Hazard: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

Hazard: 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.

Hazard: 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.

Hazard: Device does not comply with the labeling requirements of international standard IEC 60601-1.

Hazard: Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

Hazard: Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

Hazard: Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

Hazard: Potential for temporary loss of imaging (X-ray) functionality due to software issue.

Hazard: Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.

Hazard: The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

Hazard: The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

Hazard: Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.

Hazard: Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

Hazard: The Drill stop kit contains incorrect components.

Hazard: Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.

Hazard: A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

Hazard: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Hazard: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Hazard: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Hazard: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Hazard: Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.

Hazard: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

Hazard: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

Hazard: In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

Hazard: In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.