🏥 Medical Devices • 6,839 recalls
Magnolia Medical Technologies
Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Olympus Corporation of the Americas
Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
W. L. Gore & Associates
Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
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
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Epimed International
Potential for stylet to protrude from the distal end of the catheter
Delta Med SpA
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.