Inspiration LS, 5i and 7i Ventilator Systems by eVent Medical: Class I Recall - May Shut Down without Alarm
If ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - December 7, 2015 Category: American Health Source Type: news
SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections
Labeling changes describe risks of ketoacidosis, urosepsis and pyelonephritis. (Source: FDA MedWatch)
Source: FDA MedWatch - December 4, 2015 Category: American Health Source Type: news
Lipo Escultura: Recall - Undeclared Drug Ingredients
Use of product may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. (Source: FDA MedWatch)
Source: FDA MedWatch - December 4, 2015 Category: American Health Source Type: news
OmniPod Insulin Management System by Insulet: Field Safety Notification - Reported Cases of Needle Mechanism Deployment Failure or Delay
Interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis. (Source: FDA MedWatch)
Source: FDA MedWatch - December 2, 2015 Category: American Health Source Type: news
Digital Temple Thermometer (DTT) by K-Jump Health Co., Ltd.: Recall - Inaccurate Temperature Display
Manufacturing problem causes the affected thermometers to display temperatures that are lower than actual body temperatures, which may cause the user or caregiver of the user to delay or forego seeking appropriate care. (Source: FDA MedWatch)
Source: FDA MedWatch - December 1, 2015 Category: American Health Source Type: news
RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific: Recall - Wires May Break and Separate from the Rotablator System
The use of affected product may cause serious adverse health consequences, including death. (Source: FDA MedWatch)
Source: FDA MedWatch - November 27, 2015 Category: American Health Source Type: news
Compounded Multivitamins by Glades Drugs: Voluntary Recall - High Amounts of Vitamin D3 (Cholecalciferol)
Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated. (Source: FDA MedWatch)
Source: FDA MedWatch - November 25, 2015 Category: American Health Source Type: news
Intravascular Medical Devices: FDA Safety Communication - Lubricious Coating Separation
Serious adverse events reported, including pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death. (Source: FDA MedWatch)
Source: FDA MedWatch - November 23, 2015 Category: American Health Source Type: news
Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants
Labels of all iodinated contrast media (ICM) products will include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended. (Source: FDA MedWatch)
Source: FDA MedWatch - November 17, 2015 Category: American Health Source Type: news
G5 Ventilator by Hamilton: Class I Recall - Ventilation and Alarm Failure
If failure occurs, and the operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - November 14, 2015 Category: American Health Source Type: news
Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods
Identified facility violations could result in an increased risk of infection transmission. (Source: FDA MedWatch)
Source: FDA MedWatch - November 13, 2015 Category: American Health Source Type: news
Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death
FDA review determines that long-term use of clopidogrel does not increase/decrease overall risk of death in patients with, or at risk for, heart disease, and does not suggest that clopidogrel increases risk of cancer/death from cancer. (Source: FDA MedWatch)
Source: FDA MedWatch - November 6, 2015 Category: American Health Source Type: news
Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall - Intermittent Seal Failure During Use
Seal failure could result in patient blood loss. (Source: FDA MedWatch)
Source: FDA MedWatch - October 29, 2015 Category: American Health Source Type: news
Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death. (Source: FDA MedWatch)
Source: FDA MedWatch - October 29, 2015 Category: American Health Source Type: news
Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks
Drug labels for Comtan and Stalevo will remain unchanged. (Source: FDA MedWatch)
Source: FDA MedWatch - October 26, 2015 Category: American Health Source Type: news
