Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the…
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain…
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power…
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power…
The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it…
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power…
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power…
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power…
Product lidstock contains the incorrect expiration date for the product
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the…
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA…
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Browse recent months with enough recall history for useful comparison.
