Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
Class I - Dangerous
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
Boston Scientific
Class I - Dangerous
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Wound dressing may have foreign matter on the product.
Class I - Dangerous
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Class I - Dangerous
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Class I - Dangerous
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Potential for the lid of the catheter connector to be in the incorrect position.
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
MedicalCommunications GmbH
Class I - Dangerous
Potential that the measured value may be smaller than the actual area.
Class I - Dangerous
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Tandem Diabetes Care
Class I - Dangerous
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
Class I - Dangerous
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Class I - Dangerous
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Class I - Dangerous
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Boston Scientific
Class I - Dangerous
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.