The FDA has announced a voluntary global recall of more than 157,000 Ethicon surgical staplers, due to problems with incomplete firing strokes that may cause faulty staple formation, potentially resulting in painful and severe internal complications for the patient. An Ethicon surgical stapler recall was first announced in August, after reports surfaced where surgeons experienced [...]
Topic | Medical Device Recalls RSS feed for this section
Non-FDA Approved Stryker Surgical Device Recall And Alert
Stryker Neptune Waste Management System is the subject of a recent FDA recall and safety alert. The non-FDA approved device can cause bleeding as well as soft tissue, muscle and vital organ damage. The Stryker Neptune Waste Management System is used during surgical procedures to collect fluid waste from the patient. The Neptune 2 Ultra [...]
Iodine Prep Solution Deaths Prompt FDA Recall
Surgical kit maker Custom Medical Specialties used recalled iodine prep solution in its products prompting the FDA to issue a Class I recall of 14 products. The recalled iodine has been linked to serious adverse reactions, including iodine prep solution death. Recalled Iodine Prep Solution Left In Products The problem stared last year when the [...]
CareFusion’s 303 Alaris Pump Module Recalled
The FDA issued a class 1 recall of CareFusion’s 303 Alaris Pump Module, Model 8100 to a large list of recently recalled CareFusion products. The FDA’s announcement stated “potential for the pump module door keypad overlay to become loose, peel away or separate from the door assembly. This could cause a potential for fluid ingress which could lead [...]
Johnson & Johnson Unit Recalls Exploding Bone Putty
The US Food and Drug Administration has issued a recall notice about a putty used in surgery that carries a risk of exploding. Johnson & Johnson’s Synthes unit recalled its Hemostatic Bone Putty, and the FDA slapped its most serious label, Class I Recall, on the affair. The FDA reserves its Class I tag for recalls [...]
Stryker Modular-Neck Hip Implant Systems Recalled Due To Possible Corrosion Similar To Metal On Metal Implant
On July 6, 2012 Stryker Corporation voluntarily recalled its Rejuvenate and ABG II modular-neck hip stems. Modular-neck hip stems are meant to correct certain aspects of a patent’s anatomy and hip biomechanics. Recent FDA adverse event reports, however, link the product has been associated with tissue reactions resulting in pain and/or swelling. “While modular-neck stems provide surgeons [...]
GE Healthcare Recalls Ventilators Due To Safety Issue
Isn’t it a scary thought to know that a ventilator, something that keeps a person alive after a surgery or traumatic event by breathing for them, could be recalled? But it’s true, as a new recall has just been announced, and apparently just in the nick of time, as lives are possibly in danger due [...]
Recalled Surgical Device Responsible For At Least 3 Deaths
If you’ve ever had to have a surgery, you know the fear that comes along with it. Will I be ok? Is this the right thing for me to do? What will happen if I have trouble? There are just so many uncertainties, and unfortunately when going under the knife, there is nothing you can [...]
Some Can Breathe Easier Due To Ventilator Recall That Is Potentially Saving Lives
According to various media reports, Respironics Inc.’s recall of a portable ventilator model, Respironics Trilogy 100, is nearly complete, the manufacturer said Thursday, January 12, 2012. The recall was initiated in October 2011 after internal reviews discovered a problem with the blower. Respironics notified its United States distributors, providers, sales personnel and customers of the recall [...]
Recall Of Operating Tables Could Mean Life Or Death For Surgical Patient
Imagine if you will the scenario of you being operated on and all of a sudden the operating table suddenly moved or tilted during the surgery. I honestly couldn’t imagine. But, apparently there have been a number of reported injuries to the FDA of this exact thing happening. Reports that Mizuho operating tables could suddenly [...]
GET HELP NOW!
Latest Drug Injury News
Medical Mattresses Pose Risk Of Infection And Contamination
The FDA warns that medical mattresses may not be as clean as once perceived. Routine checks on mattresses are advised as any rips, tears, or excessive wear alter the efficacy. The medical mattresses as well as the covers have an expected life depending on the manufacturer, which should not go unnoticed.
On Third Of Children Medications Are Only Tested On Adults Leading To Improper UseOne third of children medications are not tested on children, but rather adults. Thus, these drugs are approved for adult use. Companies base the dosages off the adult studies, increasing the risk for improper use.
Epilepsy Drug During Pregnancy Linked To AutismExpectant mothers who take the popular anti-epileptic drug valproate during pregnancy should be aware that there is an increased risk for their child developing autism compared with children of women who did not take the epilepsy drug, according to a recently published Danish study. Valproate is a drug used for the treatment of epilepsy and other [...]
Cough Syrup Responsible For Over 36 DeathsPakistani authorities are investigating allegations that cough syrup has killed at least three dozen people, a government official has announced, making this the second time in recent months that medicine is suspected of causing multiple deaths. The deaths from the cough syrup occurred in the eastern city of Gujranwala and nearby villages, said local official [...]
Merck Settles Vioxx Class-Action LawsuitIn almost a decade old battle, Merck & Co. Inc. has agreed to settle a class action lawsuit filed on behalf of Missouri consumers over its prescription pain reliever Vioxx in a deal that could cost the drugmaker up to $220 million, lawyers for the consumers said. According to CNBC, the agreement announced on November [...]
Latest Medical Device Injury News
Metal-on-Metal Hip Implants Cause Soft Tissue Damage Says FDA
Hip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms do not respond to conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacement or hip resurfacing. As part of this treatment, they may receive a “metal-on-metal” hip implant in which the “ball and socket” of [...]
Ethicon Recalls Surgical StaplerThe FDA has announced a voluntary global recall of more than 157,000 Ethicon surgical staplers, due to problems with incomplete firing strokes that may cause faulty staple formation, potentially resulting in painful and severe internal complications for the patient. An Ethicon surgical stapler recall was first announced in August, after reports surfaced where surgeons experienced [...]
Another Device Maker Investigated By DOJEarlier this month, cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. According to Forbes, the announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had just been [...]
A Medical Device Horror StoryCNNMoney describes the chilling details of the bone cement horror stories surrounding the medical device company Synthes. In 2009 the U.S. attorney in Philadelphia accused the medical device manufacturer of running illegal clinical trials — essentially, experimenting on humans. Between 2002 and 2004, Synthes tested a product called Norian XR, a cement that has a [...]
Non-FDA Approved Stryker Surgical Device Recall And AlertStryker Neptune Waste Management System is the subject of a recent FDA recall and safety alert. The non-FDA approved device can cause bleeding as well as soft tissue, muscle and vital organ damage. The Stryker Neptune Waste Management System is used during surgical procedures to collect fluid waste from the patient. The Neptune 2 Ultra [...]
