95,114 total recalls in our database
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.
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.
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.
Arrow International
Product lidstock contains the incorrect expiration date for the product
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.
Ormco/Sybronendo
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 may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.
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.
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.
Arrow International
Product lidstock contains the incorrect expiration date for the product
Siemens Healthcare Diagnostics
Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.
Arrow International
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.
Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)
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.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Siemens Healthcare Diagnostics
Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica¿ CH Analyzer.