All Recalls

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Antivirus software was not consistently installed on impacted devices during the implementation process.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

The carabiner's automatic closing mechanism can break and prevent the gate from closing, posing a risk of serious injury or death due to falling.

The recalled battery charger violates the mandatory standard for consumer products containing button cell or coin batteries because the charger has lithium coin batteries that can be accessed easily by children. In addition, the coin batteries provided with the battery charger are not in child-resistant packaging, and the packaging does not have the warnings as 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.