All Recalls

Potential for the lid of the catheter connector to be in the incorrect position.

The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.

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.

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

Potential for the lid of the catheter connector to be in the incorrect position.

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

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.

Potential for the lid of the catheter connector to be in the incorrect position.

The recalled torches violate the requirements of the mandatory safety standard for multipurpose lighters, posing deadly fire and burn hazards to consumers.

The recalled LED tutu skirts violate the mandatory standard for consumer products containing button cell or coin batteries because the LED lights connected to the skirts contain lithium coin batteries that can be accessed easily by children. Additionally, the tutu skirts do not have the warnings required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The Power Stations may overheat and ignite, posing a risk of serious burn injury and fire hazard.

The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.

The recalled 3 mm magnetic ball sets violate the mandatory standard for toys because the magnet sets contain loose magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.