Reason for Recall: This device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.

Akreos ® posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's...

The COBAS Taqman HBV Test For Use With The High Pure System is a laboratory test kit that measures the amount of hepatitis B viral DNA in the blood of an individual infected by the hepatitis B virus (HBV). Viral DNA (deoxyribonucleic acid) is the...

The Hoya iSpheric™ Model YA-60BB IOL is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting...

This recall is being conducted due to potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump. These misconnections have resulted in a blockage (occlusion) between the sutureless pump connector...

This online newsletter about FDA regulated products for older adults and their caregivers. It focuses on FDA approved products that help people live longer, more productive lives.

Reason for Recall: The AED instructs the responder, by voice prompts, to press the shock button. However, the shock button is covered and is not visible. Therefore, the responder is not able to provide therapy (shock).

Reason for Recall: The mobile oxygen storage tank's pressure gauge may rupture and the device may catch fire as a result of hydraulic fluid present in the pressure gauge tubing.

T-Spot.TB is a laboratory test kit which contains reagents to detect the immune response of Thymus cells (T cells) found in an individual?s white blood cells that are stimulated by proteins produced by the bacteria that causes tuberculosis (TB).

The tip of the stent delivery system may detach from the delivery system during the procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Recall does not affect...

The SPOT-Light ® HER2 CISH ™ kit is a laboratory test that uses DNA probes to measure the number of copies of Her-2 gene on chromosome 17 in breast cancer cells by a chromogenic method.

Reason for Recall: Use of the Valleylab Force FX-C or Valleylab SSE2L with the CentriMag Blood Pumping System may result in stoppage of the pump and may cause serious injury or death.

Evolence® Collagen Filler is a sterile, injectable, biodegradable, yellowish, opaque gel that is injected into the inner layers of facial skin (mid to deep dermis) in order to correct moderate to deep facial wrinkles and folds such as those around the...

The Medtronic ® Attain StarFix™ Model 4195 Lead is a surgically implanted insulated wire that is designed to be used as a part of a biventricular pacemaker system. The 4195 lead is designed to be implanted in a branch of the coronary vein that goes over..

The XIENCE V Stent is a metal scaffold with the drug everolimus contained in a thin coating. The XIENCE V Stent is mounted on a folded balloon attached to a catheter delivery system, for placement into the coronary artery (blood vessel supplying blood...

The Zenith® TX2 ® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall.