All Recalls

The firm discovered a lack of adequate documentation confirming sterility on certain products.

The firm discovered a lack of adequate documentation confirming sterility on certain products.

The firm discovered a lack of adequate documentation confirming sterility on certain products.

GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported.

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.

Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.

Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

The firm discovered a lack of adequate documentation confirming sterility on certain products.

During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.

Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

The firm discovered a lack of adequate documentation confirming sterility on certain products.

The firm discovered a lack of adequate documentation confirming sterility on certain products.

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.