All Recalls

Foreign material: pieces of a pen (writing utensil).

Foreign material: pieces of a pen (writing utensil).

Foreign material: pieces of a pen (writing utensil).

Foreign material: pieces of a pen (writing utensil).

Products may be contaminated with Listeria monocytogenes.

Products may be contaminated with Listeria monocytogenes.

Products may be contaminated with Listeria monocytogenes.

Foreign material: pieces of a pen (writing utensil).

Foreign material: pieces of a pen (writing utensil).

Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.

After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration.

Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload

The sterile blister packaging may be damaged, and sterility may be compromised

Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.

A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided surgery treatment approach is selected, along with a Step-by-Step Full Drill Protocol export implant library, exoplan software does not filter out unsupported sleeve height positions for a particular sub-full drill protocol and instead shows ALL possible sleeve height positions for all sub-full drill protocols. The use of an improper sleeve height position in a surgical guide could result in patient injury

Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames