Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant…
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not…
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant…
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant…
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Marketed without a 510K
Marketed without a 510K
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant…
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas…
Marketed without a 510K
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Marketed without a 510K
There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
The pump has an impeller with a shroud height that did not meet the lower control limit.
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Browse recent months with enough recall history for useful comparison.
