Recalls 1610 articles

Cardiac support device recalled due to malfunction

Abbott is recalling nearly 5,000 HeartMate 3 Left Ventricular Assist Systems that provide cardiac support to critically ill patients due to a potential malfunction that could reduce the action of the pump and pose serious adverse events to patients including blood clots and death. The HeartMate 3 Left Ventricular Assist System helps deliver blood from the heart to the rest of the body. It is used for the short-term support of patients who are at risk of death from end-stage left ventricular heart failure, such as patients awaiting a heart transplant. The system includes a blood pump that is implanted ... Read More

Homeopathic products recalled due to quality concerns

MBI Distributing Inc., is recalling several of its homeopathic drug products used to treat a variety of ailments from colic to cough because they were found to be manufactured without adequate controls to ensure the products’ strength, quality and purity. Use of these products could cause health problems especially in vulnerable patients, like the infants and children for which many of the products are intended. To date, MBI Distributing has not received any reports of adverse events related to this recall. Products affected by the recall include all lots of MBI Distributing Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, ... Read More

Fiat-Chrysler Recalls Nearly 5 Million Vehicles For Cruise-Control Glitch

Fiat-Chrysler is recalling nearly 5 million U.S. vehicles to repair a software glitch that could prevent drivers from canceling the cruise control. The problem affects about 4.8 million Fiat-Chrysler cars, minivans, SUVs, and pickup trucks from model-year 2014 to 2018. According to the automaker, “a driver could be unable to cancel cruise-control” if the cruise control system accelerates at the same time a “short-circuit in a specific electrical network” occurs. Normally drivers disengage cruise control by tapping the brake or hitting the cruise-control on-off switch, but both methods can stop working if the glitch occurs. The National Highway Traffic Safety ... Read More

FDA recalls supplements containing illegal prescription drugs

Shoreside Enterprises Inc., is recalling two dietary supplements promoted for male sexual enhancement after an analysis conducted by the Food and Drug Administration (FDA) revealed the products contained undeclared pharmaceutical drugs. The affected supplements – 7K and Poseidon 4500/Extreme 1000 mg  – contain sildenafil and/or tadalafil, the active ingredients in the prescription erectile dysfunction drugs Viagra and Cialis, respectively. Not only does the presence of these drugs in the dietary supplements render them unapproved drugs for which the safety and efficacy cannot be established, they also pose health risks to some people. Sildenafil and tadalfil may interact with nitrates found ... Read More

Lawmaker Questions FDA’s Handling of Egg Recall

A multistate outbreak of Salmonella poisoning linked to eggs and the weak response of federal regulators has Representative Rosa DeLauro (D-Conn.) concerned and full of questions. On May 21, Rep. DeLauro sent a letter to U.S. Food and Drug Administration (FDA) Administrator Scott Gottlieb seeking more information about what steps the agency has taken in response to the Salmonella outbreak, which has sickened at least 35 people in 11 states. Eleven of the sickened people have been hospitalized with more severe infections. The problem first came to light on April 13, when the FDA announced a recall of more than ... Read More

Apotex recalls combination antibiotic injection

Apotex Corp. is recalling 36 lots of the injectable antibiotics Peperacillin and Tazobactam after finding that they contain elevated levels of impurities that may decrease their potency. The product is manufactured by Hospira Inc., a Pfizer Company, and distributed in the U.S. by Apotex Corp. Decreased potency of Peperacillin and Tazobactam could result in worsening of the infection being treated and under extreme circumstances lead to serious conditions depending on the severity of the patient’s illness. Elevated levels of impurities may result in various toxicities, such as liver, renal and hematological toxicities. To date, the company has received no reports ... Read More

Resuscitation device recalled due to design error

Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in product design that may make it difficult or unable to disconnect the mask from the elbow of the resuscitator. This could cause a delay in or an inability to provide necessary ventilation to the patient and potentially result in serious patient injury, including death. The Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit are manual resuscitation devices that are used together as one pair to provide constant ventilation to adults and children who are not breathing or cannot adequately breathe on their ... Read More

Dräger Medical recalls anesthesia machines

Dräger Medical is recalling its Fabius Anesthesia machines because they may have excessive oil that was not removed during production of the machines. This oil may interfere with the position detector of the ventilation motor during operation and cause the ventilation to fail, which can lead to serious patient injury or death. The recall affects several lots of Fabius Anesthesia machines including Fabius GS Premium, Fabius Tiro, Fabius Tiro M, and Fabius MRI. A total of 62 machines are being recalled from the following states: Arizona, California, Colorado, Idaho, Illinois, Kansas, Massachusetts, Michigan, Mississippi, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, ... Read More

Recalled Harbor Freight Chainsaws Pose Serious Injury Risk

Harbor Freight Tools said it is recalling two models of chainsaws sold under different brand names for a switch problem that could seriously injure the operator. The Camarillo, California-based retailer says the power switch on the chainsaw models under recall can malfunction, remaining on after the operator moves it to the off position. The problem can cause lacerations, amputations and other serious injuries. According to the U.S. Consumer Product Safety Commission’s (CPSC) May 14 recall notice, Harbor Freight said it received 15 reports of chainsaws failing to shut off. Three of the reports included lacerations to the operator, including one ... Read More

Spike in drug, device recalls in 1Q 2018

Pharmaceutical and medical device companies issued an unusually high number of recalls during the first quarter of 2018, according to the U.S. Recall Index compiled by Stericycle Expert Solutions. Drug recalls jumped 52 percent to 105 – the highest number since the third quarter of 2013. Most – about 22 percent – were due to failed specifications, a cause that has been leading drug recalls for the seventh consecutive year. Medical device recalls jumped 126 percent to 343 in the first quarter of 2018, more than doubling the number of recalls posted last quarter. It was the largest increase since ... Read More