Complete FDA and NHTSA recall records dated in May 2019.
These records include useful source details for the selected month.
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.
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.
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
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
Devices were delivered without the required dry ice.
Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
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.
Devices were delivered without the required dry ice.
The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
The kits may contain the incorrect number of components or the kits may be missing components.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and…
Product design change did not receive proper premarket clearance and lacks a 510 (k)
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.
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.
