SPOTCHEM II Test Strips by Arkray: Class I Recall - Inaccurate Blood Sugar Readings
Because the test strips are reporting falsely low blood glucose, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) in a timely manner and fail to treat elevated blood glucose levels. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - January 28, 2016 Category: American Health Source Type: alerts
Crema Piel De Seda (Silky Skin Cream) by Viansilk: Consumer Warning - Risk of Mercury Poisoning
Exposure to mercury can cause serious health problems, such as kidney and nervous system damage. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - January 28, 2016 Category: American Health Source Type: alerts
MOVES Ventilator System by Thornhill Research: Class I Recall - Battery Problem
The issue may prevent the ventilator from providing patient breathing support and could cause patient injury or death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - January 27, 2016 Category: American Health Source Type: alerts
Baxter IV Solutions (Select Lots): Recall - Potential for Leaking Containers and Particulate Matter
Solution contamination could lead to a worsened patient condition or death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - January 27, 2016 Category: American Health Source Type: alerts
Optisure Dual Coil Defibrillation Leads by St. Jude Medical: Class I Recall - Damage May Prevent Patient Therapy
Manufacturing error may have caused damage to the insulation layer of one of the shock coils. This could result in the inability of the defibrillator to deliver electrical therapy to the patient. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - January 26, 2016 Category: American Health Source Type: alerts
Licorice Coughing Liquid OTC Cough Syrup by Ma Ying Long Pharmaceutical Group: CDER Alert - Contains Unidentified Morphine
Effects of morphine can include, but are not limited to, severe allergic reactions, respiratory depression, and death. (Source: FDA MedWatch)
Source: FDA MedWatch - January 16, 2016 Category: American Health Source Type: news
Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance
Products include injectable medications, sterile solutions, eye drops, and eye ointments. (Source: FDA MedWatch)
Source: FDA MedWatch - January 16, 2016 Category: American Health Source Type: news
Brainlab Cranial Image-Guided Surgery (IGS) System: Class I Recall - Navigation Inaccuracy
Potential inaccuracies in the display by the navigation system could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death. (Source: FDA MedWatch)
Source: FDA MedWatch - January 15, 2016 Category: American Health Source Type: news
Children's Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid by Perrigo Company: Recall - Potential Defect with Dosage Cup
An overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma. (Source: FDA MedWatch)
Source: FDA MedWatch - January 13, 2016 Category: American Health Source Type: news
Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman - Class I Recall - Catheter May Break During Insertion
May cause serious patient injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - January 11, 2016 Category: American Health Source Type: news
Multiple Products by R Thomas Marketing: Recall - Undeclared Drug Ingredient
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. (Source: FDA MedWatch)
Source: FDA MedWatch - January 9, 2016 Category: American Health Source Type: news
L.G Compounded Asafoetida Powder by Shakti Group: Recall - Potential Contamination with Salmonella
Salmonella can cause fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. (Source: FDA MedWatch)
Source: FDA MedWatch - January 8, 2016 Category: American Health Source Type: news
Evita V500 and Babylog VN500 Ventilators by Dräger: Class I Recall - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly
If the ventilator shuts down, a patient may not receive necessary oxygen, which could cause patient injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - January 6, 2016 Category: American Health Source Type: news
Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container
Potential for delay in treatment that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise. (Source: FDA MedWatch)
Source: FDA MedWatch - January 6, 2016 Category: American Health Source Type: news
Surgical Convenience Packs and Trays by Customed, Inc.: FDA Safety Communication - Do Not Use
The integrity, safety and efficacy cannot be assured because of inadequate testing. Use of these products pose a risk of serious adverse health consequences, such as infection and death. (Source: FDA MedWatch)
Source: FDA MedWatch - January 5, 2016 Category: American Health Source Type: news
