Complete FDA and NHTSA recall records dated in February 2020.
These records include useful source details for the selected month.
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.
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
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…
Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to…
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
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.
Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and…
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…
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…
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.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
