Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 805–816 of 845 recalls
Potential for hole in package compromising sterility of the medical kit.
Potential for hole in package compromising sterility of the medical kit.
Potential for hole in package compromising sterility of the medical kit.
Potential for hole in package compromising sterility of the medical kit.
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.