Class I - Dangerous
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.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Ormco/Sybronendo
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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 FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
Arrow International
Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.
Siemens Healthcare Diagnostics
Class I - Dangerous
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 Central Venous Catheterization Kit ASK-04200-UPM
Arrow International
Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay
Siemens Healthcare Diagnostics
Class I - Dangerous
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.
Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Medicrea International
Class I - Dangerous
Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
Class I - Dangerous
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Class I - Dangerous
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 sterile during their shelf-life.
Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Class I - Dangerous
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.
Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.