Medical device recalls

When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane

Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane

Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane

The distal tip ring of the fully articulating catheter may become dislodged during the procedure.

Potential increased occurrence of pump fracture over the lifetime of the device.

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur

Under certain conditions, there is a risk for fire.

Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.

There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.

There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.

There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.

There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.

If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.

Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.

Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.

Incorrect hip components were provided in kits.

Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.

Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.