Search

Philips Respironics has discovered that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FioO2 sensor may indicate a value…

During a ventilation sequence, the user started the "100% O2" function. This function lasts for two minutes but can be interrupted by pressing the 100% O2 key. Note: after the 100% O2 function has been used, the FiO2 setpoint originally entered is…

The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning…

During internal testing, regulatory compliance issues regarding fluid ingress and basic safety issues have been identified with the Tempus Pro monitor, ac mains power supply, and the vehicle adaptor. the tempus pro device's labeling indicates that the…

Potential low Anti-Factor Ila potency out of specification.

Bacteria content is below specification in the affected lot.

Bacteria content is below specification in the affected lot.

Affected lots are incorrectly labelled for use in the pediatric subpopulation.

Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall…

The affected products were manufactured using unvalidated materials that can result in unsealed packaging for the individual syringes. Recall start date: February 3, 2023

This medical device recall (correction) has been initiated due to certain lots labeled with incorrect expiration dates. The labeled expiration dates of impacted products were printed with a 10-year expiration date however, the products have an…

The dissolution is out of specification in the affected lot.

It was identified that two (2) Freestyle Libre sensor reel lots manufactured by Abbott Diabetes Care (ADC) failed retain testing. As a result of the investigation and testing of retains, the sensors were found to give clinically significant readings…

Affected lot being voluntarily recalled due to reported adverse reactions possibly to niacin (reddening skin flush, heat sensation).

The affected lot may contain the presence of foreign matter.