95,025 total recalls in our database
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
NOX MEDICAL
Error in the device firmware results in the inaccurate detection of device position.
ZOLL Circulation
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aesthetics Systems Usa
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
ZOLL Circulation
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Medtronic Perfusion Systems
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing