Medical Devices Recalls

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

Potential for a wire protrusion through the left heart vent catheter tip

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

There is potential for packaging defects that may impact the sterile barrier.

Malfunction- loosening of the implant resulting in a potential revision surgery

As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

Incorrect version of labels were used.

Sterility assurance may be compromised.

Sterility assurance may be compromised.

There is a potential for open seals which can compromise sterility.

There is potential for packaging defects that may impact the sterile barrier.

Incorrect version of labels were used.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.