All recalls

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.

The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.

Pumps were released without full testing being performed, including occlusion alarm testing.

Due to damage to outer tray that can potentially compromise the sterile barrier

Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.

Potential packaging failures, which could lead to a breach in the sterile barrier.

Potential packaging failures, which could lead to a breach in the sterile barrier.

Potential packaging failures, which could lead to a breach in the sterile barrier.

Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

Issue with software algorithm which may lead to overpressure events.

Issue with software algorithm which may lead to overpressure events.

Issue with software algorithm which may lead to overpressure events.

Label declares bovine colostrum but does not declare milk allergen.

Undeclared fish allergen (tuna). Tuna Salad was mislabeled as Chicken Salad.