Medical Devices Recalls

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to distributing the measles IgG IVD without a premarket approved/cleared.

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to incorrect product label (Incorrect product name identified on outer packaging).

Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.