FDA Press Releases Archives - Page 386 of 802

Cyberonics Vagus Nerve Stimulator Recalls

November 26, 2018 By Sandra Dalton Leave a Comment

So far, there have been at least six recalls of model 106 generators used to power Cyberonics vagus nerve stimulator (VNS) therapy systems. The VNS therapy systems are implanted devices used to treat seizures and epilepsy. The U.S. Food and Drug Administration (FDA) has received more than 10,000 reports of injuries and death in people who have … [Read more...]

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

November 26, 2018 By The FDA Leave a Comment

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare® HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap. The use of a leaking/damaged heat cell wrap … [Read more...]

Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Product

November 24, 2018 By The FDA Leave a Comment

Ottogi America, Inc. of Gardena, California announced today it is recalling 1lb 5.16ounce of Jin Ramen Mild 5pk. (Best Before Aug. 19th 2019) and Jin Ramen Spicy 5pk. (Best Before Aug. 20th 2019) due to undeclared egg as an ingredient on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or … [Read more...]

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

November 23, 2018 By The FDA Leave a Comment

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been … [Read more...]

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

November 21, 2018 By The FDA Leave a Comment

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two … [Read more...]