All Recalls

An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.