Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review
FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo.

Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication
Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use.

Vicks Sinex Nasal Spray - Recall
Product found containing the bacteria B. cepacia.

RockHard Weekend - product contains undeclared drug ingredient
Recall of product, sold as a dietary supplement, containing undeclared sulfoaildenafil.

Cardiovascular Systems ViperSheath Sheath Introducer - Recall
Nationwide recall due to stretching or fracture of the sheath during use.

IDS Sports Dietary Supplements - Recall
Five products marketed as dietary supplements contain undeclared substances considered to be steroids.

Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction
Effectiveness of clopidogrel is reduced when taken with omeprazole, placing patients who use clopidogrel to prevent blood clots at risk for heart attacks or strokes if they are also taking omeprazole.

Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification
Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT.

Pai You Guo, Marketed as Dietary Supplement - Recall
Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein.

Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis
Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices.

Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen
Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions.

Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall
Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device.

External Biphasic Defibrillators Energy Levels: Initial Communication
14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient.

Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall
Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery.

Hospira Brand Propofol and Liposyn Products - Recall
Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow.

Stiff Nights - product contains undeclared drug ingredient
Consumers warned that product sold as a dietary supplement contains sulfoaildenafil.

Centurion Medical Products - Premie Pack and Meconium Pack - Recall
Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label.

Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall
Nationwide recall due to the potential for particulate matter in conjunction with crystallization in the product.

Dietary Supplements Sold on Internet by Bodybuilding.com
Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury.

Unomedical Manual Pulmonary Resuscitator - Recall
Recall due to malfunction which impairs ability of device to generate positive pressure necessary to function properly.