All Recalls

The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

Uncertainty in the seal integrity of the sterile packaging.

Predict+ is being recalled for lack of pre-market clearance/approval.

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.

The recalled ATVs fail to comply with the requirements of the federal mandatory ATV safety regulations. The youth ATVs' mechanical suspension fails to comply with safety requirements, posing a crash hazard. The adult ATVs' service brakes fail to sufficiently stop the vehicle, posing a crash hazard, and the handlebars pose a laceration hazard if the adult rider's body or head impacts the handlebars. ATVs that fail to meet the mandatory safety regulations pose a risk of serious injury or death.

Soy Sauce is declare but Wheat and Fish (Anchovy) are not declared.

Soy Sauce is declared but Wheat is not declared.

Product is labeled as electrolytes but is actually caffeine

FD&C Red No 3 was not declared as an ingredient.

Undeclared Fish (Anchovy).