95,025 total recalls in our database
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 sterile during their shelf-life.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Arrow International
Product lidstock contains the incorrect expiration date for the product
Philips North America
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Smith & Nephew
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 puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
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 alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.
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.
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 standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Arrow International
Product lidstock contains the incorrect expiration date for the product
Philips Medical Systems Gmbh, DMC
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 thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
The product do not meet certain internal testing specifications.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Arrow International
Product lidstock contains the incorrect expiration date for the product
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Philips North America
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Product lidstock contains the incorrect expiration date for the product
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 alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.