Other Medical Devices

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.

The electrical safety testing was not properly performed on the impacted devices and additional testing is required

A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.

Presence of misleading label statements on the product label.

Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.

Presence of misleading label statements on the product label.

The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.

Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.

Risk of mechanical instability due to potential manufacturing error of the device

Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.

The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.