All Recalls

Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.

EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.

Potential breach of the sterile barrier packaging.

Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.

The cutting efficiency of the Countersinks was out of specification.

Customer complaints reporting that the cobb connector detached from the main connector prior to use.

Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.

Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Customer complaints reporting that the cobb connector detached from the main connector prior to use.

Customer complaints reporting that the cobb connector detached from the main connector prior to use.

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Charging base of surgical clippers overheats and smokes.

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.

Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.

Potential breach of the sterile barrier packaging.

Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to a state in which X-rays are being produced but the X-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated.