Medical device recalls

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypassed and result in emission of class lIlb laser radiation. This issue arises when a ZEISS inverted stage stand (Axio Observer or Axio Vert) is used in as a component of the LSM 700, 800 and 900 system

The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.

An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.

The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one (1) of each type.

Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.

Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment

Pinion gear may disengage from track allowing lift to slip or jolt.

At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This malfunction can cause overtreatment, which could result in strong erythema, and possibly cause blisters.

The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items.

A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

During an FDA audit, it was discovered that the product was not properly registered with FDA.