All Recalls

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032

Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.

Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

Potential for positively biased results due to signal reduction over shelf life.

There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

The recalled mattresses violate mandatory federal flammability regulations for mattresses, posing a fire hazard to consumers.

When the recalled 3D printer's heatbed cable is bent or damaged, it can short-circuit and spark or burn through the insulation layer, posing electric shock and fire hazards.

The unit's serial plate can have incorrect electrical ratings which can lead to incorrect wirings being used, posing a fire hazard.

The recalled magnetic chess games, which include 20 magnet pieces, violate the mandatory federal toy magnet regulation because the set contains one or more magnets that fit within CPSC's small parts cylinder, and the magnets are stronger than permitted. When high-powered magnets are swallowed, the ingested magnets can attract each other, or another metal object, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.

The roll-on warmer's power cord can overheat and short circuit, posing fire, burn, and electrical shock hazards.