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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results
The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.