These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.
3,609 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Multi-state outbreak of E. coli O157:H7.
catheter may experience resistance when being advanced over the guidewire
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
product tested positive for Listeria Monocytogenes.
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.
catheter may experience resistance when being advanced over the guidewire
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Multi-state outbreak of E. coli O157:H7.
Multi-state outbreak of E. coli O157:H7.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
Multi-state outbreak of E. coli O157:H7.
Multi-state outbreak of E. coli O157:H7.