Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 123 recalls
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S.…
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S.…
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S.…
Software issue that renders the touch screen unresponsive.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP.…