The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.
Category Archives: Food & Drug Recalls
FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation
FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.
FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice
FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.
Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower
Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.
Medtronic Announces Worldwide Voluntary Field Corrective Action; Company Issues Software Update for Puritan Bennett™ 980 (Pb980) Ventilator Series
Medtronic (NYSE:MDT) is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett™ 980 (PB980) ventilator series.
Medtronic initiated this field action on September 19, 2018.
Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety
FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship
FDA’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship
Adam Bros. Farming, Inc. Recalls Red and Green Leaf Lettuce and Cauliflower Because of Possible Health Risk
Adam Bros. Farming, Inc. of Santa Maria, California is recalling red leaf lettuce, green leaf lettuce and cauliflower harvested on November 27 through 30, 2018 out of an abundance of caution, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7).
Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”
ATHERSTONE FOODS INC of Richmond, CA is recalling 14.6 ounce (414g) Greens and Grains Hummus and Quinoa Tabouleh Wrap, because it may contain undeclared soy, people who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard
Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.