Medical Devices Recalls

Hazard: Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.

Hazard: One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.

Hazard: System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.

Hazard: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

Hazard: Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

Hazard: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

Hazard: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

Hazard: inability to reprogram one device

Hazard: Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the detection of a change in a patient condition

Hazard: Product was distributed in the United States without proper regulatory approval.

Hazard: Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Hazard: Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Hazard: Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Hazard: There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

Hazard: There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

Hazard: Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating

Hazard: Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating

Hazard: Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years.

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell