All Recalls

Kits contain leaking bottles of isopropyl alcohol

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

The device may potentially cause a fire, leading to a safety risk.

Kits contain leaking bottles of isopropyl alcohol

Kits contain leaking bottles of isopropyl alcohol

There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.

There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.

Device was marketed without FDA 510(k) clearance or a PMA.

Kits contain leaking bottles of isopropyl alcohol

Kits contain leaking bottles of isopropyl alcohol

Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.

An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.

Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.

Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.

Kits contain leaking bottles of isopropyl alcohol