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.
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Devices were delivered without the required dry ice.
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Devices were delivered without the required dry ice.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
Product design change did not receive proper premarket clearance and lacks a 510 (k)
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Devices were delivered without the required dry ice.
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