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FDA 626 articles

FDA Cleared Metal-on-Metal Hip Implants without Clinical Testing

metal on metal hip parts

When Consumer Reports did an investigation regarding the FDA and approved medical devices designed to be implanted into the body, what they found was disturbing to say the least. “Medical devices often aren’t tested before they come on the market,” Consumer Reports says. That was the case for the DePuy ASR XL metal-on-metal hip that has allegedly injured thousands of patients, including Stephen Tower, M.D., a 55-year-old orthopedic surgeon. About a year after receiving his hip implant, Tower could tell that something was wrong. He experienced pain from his hip “pretty much constantly”, his chromium and cobalt blood levels were through the roof, ... Read More

Reports of Injuries and Deaths Linked to Retrievable IVC Filters

IVC filter

Retrievable IVC (inferior vena cava) filters are cage-like devices that are implanted into the largest vein in the body – the inferior vena cava – and are intended to catch blood clots before they enter the heart and/or lungs. This method is intended to prevent pulmonary embolism from occurring, and is often used in patients that cannot tolerate blood thinning medication. But as patients are sustaining injuries linked to flaws in the design of the IVC filters, lawsuits are pouring in against the IVC filter makers such as C.R. Bard and Cook Medical. When Gloria Adams, age 55, had a ... Read More

C.R. Bard slapped with warning for marketing IVC filter removal device without FDA approval

IVC filter

When the U.S. Food and Drug Administration (FDA) inspected two C.R. Bard facilites, its findings were significant enough to issue a serious warning letter. Bard is a medical technology developer and manufacturer, and the maker of retrievable IVC (inferior vena cava) filters that have been linked to numerous reports of patient injuries and deaths. The letter specifically addresses the Recovery Cone Removal System, Model RC-15, which is a device designed to remove retrievable IVC filters such as the Recovery Filter, the G2X Filter, the G2 Express Filter, and the G2 Filter. However, the device was being marketed without required clearance or approval, ... Read More

FDA notifies public, Boston Scientific may have used counterfeit raw materials in surgical mesh

transvaginal mesh

The Food and Drug Administration wants health care professionals and patients to be aware that they are in the process of investigating allegations that Boston Scientific used counterfeit raw materials in its urogynecologic surgical mesh products. Additional testing is being done to determine if the mesh manufactured using the raw materials that have come under recent allegations is equivalent to the mesh originally approved by the FDA. The tests will also address the safety and effectiveness of the final product. The FDA anticipates these tests lasting several months and it will update its webpage with new information as it becomes available. It ... Read More

Gerber announces baby food recall after learning organic products may be contaminated

Recall - baby food, Gerber organic - wikimedia commons image

A baby food recall has been announced by Gerber Products Company after it was informed that a packaging defect have allowed two organic baby foods to spoil during transport and handling. Gerber reports that the baby food recall impacts two kinds of Gerber Organic 2nd Foods Pouches – the Pears, Carrots and Peas mix and the Carrots, Apples and Mangoes mix. The recalled Pears, Carrots and Peas pouch was sold in two variations:  batch number 51945335XX and a best-by date of July 12, 2016, as well as batch number 51955335XX and best-by date July 13, 2016. The recalled Carrots, Apples ... Read More

Bumble Bee Foods announces tuna recall due to lack of proper steralization

tuna recall Bumble Bee - Flickr by Rusty Clark

More than 31,000 cans of tuna are now under recall by Bumble Bee Foods upon the discovery that there were deviations from the standard sterilization process. If the products were not properly sterilized upon shipping, the tuna may be contaminated by spoilage organisms or pathogens. Consumption of contaminated products could result in life-threatening illness. The tuna products impacted by the recall were produced in February 2016 with can codes starting a “T” and feature the following “best-by” dates: Label UPC Product “Best By” Dates” 8660000020 5oz Bumble Bee Chunk Light Tuna in Water 02/10/2019, 02/16/2019, 02/17/2019, 02/18/2019, 02/22/2019, 02/23/2019, 02/25/2019 ... Read More

Five Types of Retrievable IVC Filters Prone to Failure

IVC filter

A retrievable inferior vena cava filter (IVC filter) is a small cage-like device made of metal that is designed to stop a blood clot from traveling to the lungs, resulting in pulmonary embolism. But for some people, the risks outweigh the benefits for using the retrievable IVC filter. The device was originally introduced in 1979 and has been used in hundreds of thousands of patients. There are several situations in which a doctor may recommend using an IVC filter: car accidents, voluntary or emergency surgeries, gunshot victims, stabbing victims, dialysis treatment, spinal cord injury, cancer diagnosis/treatment, or in the case of serious falls. ... Read More

Pistachio recall expanded amid fears of Salmonella contamination

Pistachio - commons Wikimedia

According to the U.S. Food and Drug Administration (FDA), Texas Star Nut & Food Company has announced an expansion of its previous pistachio recall issued last week to include more products. The company believes the expansion was necessary considering the risk that the pistachios may have been contaminated with Salmonella. Salmonella poisoning is a very serious illness with side effects including diarrhea, fever and abdominal cramps. Symptoms can start as early as 12 to 72 hours after infection and may become deadly for young children, the elderly, or individuals with poor immune systems if the organism enters the sufferer’s bloodstream. ... Read More

Nestlé recall: Certain DiGiorno, Lean Cuisine, and Stouffer’s Products May Contain Broken Glass

Recall - DiGiorno pizza

Nestlé USA announced a national recall Thursday of a variety of DiGiorno, Lean Cuisine, and Stouffer’s-brand products due to the presence of glass pieces. The recall applies to the following products but is limited to certain specific production codes: DiGiorno Thin & Crispy Spinach and Garlic Pizza DiGiorno Rising Crust Spinach and Mushroom Pizza DiGiorno pizzeria Thin Crust Spinach and Mushroom Pizza DiGiorno pizzeria Tuscan-style Chicken Pizza Lean Cuisine Spinach and Mushroom Pizza Lean Cuisine Spinach Artichoke Ravioli Lean Cuisine Ricotta and Spinach Ravioli Lean Cuisine Spinach, Artichoke & Chicken Panini Lean Cuisine Mushroom Mezzaluna Ravioli Stouffer’s Vegetable Lasagna (10 ... Read More

FDA and DOJ restricts Henry’s Farm from bean sprout production after Listeria contamination

mung bean sprouts - Wiki

The U.S. Food and Drug Administration (FDA) announced the United States District Court of Virginia has entered a consent decree of permanent injunction between the U.S. and Henry’s Farm, Inc., and its owner Soo C. Park as a result of serious food safety violations related to soybean sprouts. Henry’s Farm is located in Woodford, Va. The consent decree prohibits the company from receiving, processing, manufacturing, preparing, packing, holding and distributing any ready-to-eat soybean and mung-bean sprouts after Henry’s Farm, Inc., was found guilty of violating several federal food safety laws and regulations. In order to bring the sprouts producer to justice, the FDA sought ... Read More