All Recalls

Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.

Kit packaging may have small holes compromising product sterility

Kit packaging may have small holes compromising product sterility

Kit packaging may have small holes compromising product sterility

The incorrect product is contained in the packaging.

Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.

In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

The kit contains a non-sterile needle.

Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.

Kit packaging may have small holes compromising product sterility

Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.

Probiotic products contaminated with Pseudomonas aeruginosa .

potential for glass and metal in product

potential for glass and metal in product

The firm was notified by customers that the product contained metal fragments

potential for glass and metal in product

Foreign object found in bottle