Regulatory Affairs Syndicator

These teethers may contain harmful bacteria (Bacillus circulans and Bacillus subtilis) in the gel. Use of this product may result in diarrhea, respiratory illness, serious infection, and death.

The POWERSAIL Coronary Dilatation Catheter is used by physicians during medical procedures to dilate heart blood vessels or to dilate implantable stents.

Sculptra Aesthetic is an implant of poly-L-lactic acid (PLLA) microparticles. It is injected into the facial tissue to correct shallow to deep smile lines (nasolabial fold) contour deficiencies and other facial wrinkles.

The TAXUS® Liberte? Long (2.75?4.00 mm x 38 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface.

Reason for Recall: Power supply failures have occurred on some ventilators. A power surge may exceed the power supply capacity, causing the power supply to lose power.

The TAXUS® Liberté® Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface.

Reason for Recall: The Kappa and Sigma pacemakers in these identified series may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

This device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates.

Reason for Recall: The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, CK-MB, and myoglobin, possibly resulting in missed or incorrect diagnosis.

REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG).

Reason for Recall: The ventricular catheter may become detached from the snap base assembly after implantation and may increase the need for emergency corrective surgery.

The device may experience: Low defibrillation energy delivery, Unexpected device shutdown, and/or Inadequate filtering of electromagnetic noise.

What is it? A totally implanted brain stimulator intended to suppress symptoms associated with Obsessive Compulsive Disorder (OCD) that are not adequately controlled with medications and/or other therapies.

The E-LUMINEXX Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries).

Reason for Recall: Some packages were mislabeled. The syringes labeled for use with U-40 unit insulin were mixed with syringes labeled for use with U-100 insulin.