FDA Warning & Recall Information

In a September 8, 2022 communication, the FDA announced it had been made aware of reports of cancers, including squamous cell carcinoma (SCC) and a number of lymphomas, in the scar tissue (capsule) of patients who had gotten breast implants. As a clarification, officials noted […]

The FDA is calling to attention an Urgent Medical Device Correction issued by Baxter International Inc. on March 10, 2023, regarding its Life2000 Ventilation System when the product is connected to a third-party oxygen concentrator. According to the company, patients using the device with an […]

On March 7, 2023, Natural Solutions Foundation announced a recall of its “Dr. Rima Recommends Nano Silver 10ppm” dietary supplement after the FDA determined that the product labeling makes unsupported health claims about its prevention, treatment, cure of COVID-19. The FDA maintains that consumers who […]

In a communication posted on March 7, 2023, the FDA is urging healthcare professionals to be aware of potential patient exposure to toxic compounds in hemodialysis and peritoneal dialysis systems during an ongoing investigation into the issue. Both hemodialysis and peritoneal dialysis systems are used […]

According to the FDA, Daiso California LLC has recalled as many as 10 pre-packaged snack products from its stores across six states due to undisclosed allergens. Inadequate labeling on the assorted products presents a risk to people who are allergic to, or have a serious […]

Six lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% by Apotex Corp. have been voluntarily recalled at the consumer level, according to an FDA announcement published March 2, 2023. In a press release sent just a day earlier, the Weston, Florida-based company said it learned that […]

On March 3, 2023, Phoenix, Arizona-based Pharmedica USA LLC announced a voluntary recall of two lots of Purely Soothing, 15% MSM Drops due to non-sterility. In its risk statement, the company notes that anyone using non-sterile or contaminated eye drops risks suffering eye infections that […]

Kansas City, Missouri-based Russell Stover Chocolates has issued an allergy alert and a voluntary recall of its Sugar Free Peanut Butter Cups under two Best-Before dates due to possible undeclared pecans, reports the FDA. The move was made on February 28, 2023, after a number […]

The FDA is informing healthcare providers of an issue regarding potential insufficient packaging sterility in the HLS Set Advanced part of the Getinge/Maquet Cardiohelp system.  Used to oxygenate and remove carbon dioxide from blood as it pumps through the extracorporeal bypass circuit for circulatory and/or […]

On February 27, 2023, the FDA alerted healthcare providers that it has reason to believe Abbott Trifecta valves may be subject to early structural valve deterioration (SVD). The referenced devices include both the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which […]

On February 27, 2023, the FDA released an update to a safety communication regarding the use of Apyx Medical’s Renuvion/J-Plasma Device system in certain aesthetic skin procedures. As of this writing, Renuvion APR Handpiece by Apyx Medical has been approved for “the delivery of radiofrequency […]

The FDA is calling to attention a voluntary recall of one batch of Delsam Pharma Artificial Eye Ointment by Global Pharma Healthcare because of potential microbial contamination. Though the company has not received any reports of adverse events, it recalled Batch Number H29 of the […]