Complete FDA and NHTSA recall records dated in December 2024.
These records include useful source details for the selected month.
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric…
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This…
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This…
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This…
Due to pin coming off of handles.
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
