Complete FDA and NHTSA recall records dated in May 2019.
These records include useful source details for the selected month.
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.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Potential performance issues in the Alinity-ci software version 2.5.1
Devices were delivered without the required dry ice.
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
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.
