95,025 total recalls in our database
High Performance Formulas, L.L.C. (HPF, L.L.C.)
Marketed Without an Approved NDA/ANDA
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Philips Respironics
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
Boston Scientific
Potential for leaks and loosening at the patient catheter connection
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
Philips North America
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
Philips North America
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Philips North America
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Philips North America
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
Teleflex Medical Europe
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Epimed International
Potential for stylet to protrude from the distal end of the catheter
OPTI Medical Systems
The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device