Covidien Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product recall — FDA Z-1282-2020
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are…
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
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…
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…
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…
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
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…
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…
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
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…
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 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…
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…
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer…
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
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…
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…
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Browse recent months with enough recall history for useful comparison.