Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
22,462 detailed records are currently available in this category.
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…
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Due to pin coming off of handles.
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…
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
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.
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
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.
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
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.
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…
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.
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…
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.
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.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
