Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
Arrow International
🏥 Medical Devices Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
All Recalls
95,114 total recalls in our database
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Philips Medical Systems Gmbh, DMC
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
The product do not meet certain internal testing specifications.
🏥 Medical Devices Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Arrow EPIDURAL CATHETERIZATION KIT CK-02220
Arrow International
🏥 Medical Devices Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Philips North America
🏥 Medical Devices Class I - Dangerous
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
🏥 Medical Devices Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
🏥 Medical Devices 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.
🏥 Medical Devices 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.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
🏥 Medical Devices Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Ormco/Sybronendo
🏥 Medical Devices 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.
🏥 Medical Devices 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.
🏥 Medical Devices 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.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
🏥 Medical Devices Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
🏥 Medical Devices Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.