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693 stories matching this filter · ← front page

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  • Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
    The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit. The alert says that particulates coul…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug
    The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of t…
    fda medwatch · 4mo agoCRLNegative↗ source
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  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Windstone Medical issues correction for non-sterile alcohol prep pads in custom convenience kits
    Windstone Medical Packaging, Inc. has released a correction notice for several custom convenience kits that include Cardinal Health Webcol large alcohol prep pads that were found to be non-sterile.…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Yusol International Foods recalls OLA-OLA Pounded Yam over undeclared milk allergen
    Fayus Inc., operating as Yusol International Foods, announced a voluntary recall of its OLA-OLA Pounded Yam product after discovering that some packages contain sodium caseinate, a milk-derived ing…
    fda recalls · 4mo agoCRLNegative↗ source
  • Chile's Frutas y Hortalizas del Sur recalls frozen organic blueberries over possible E. coli O145 contamination
    Frutas y Hortalizas del Sur S.A., based in San Carlos, Chile, announced a recall of its frozen GreenWise Organic IQF Blueberries (10‑oz) because the product may be contaminated with Escherichia col…
    fda recalls · 4mo agoCRLNegative↗ source
  • Mars Petcare voluntarily recalls two lots of Pedigree high-protein wet dog food over possible metal and plastic contamination
    Mars Petcare US announced a voluntary recall of two lots of Pedigree Can High Protein Chopped Chicken & Duck Flavor wet dog food (13.2 oz) after discovering potential foreign material. The recall…
    fda recalls · 4mo agoCRLNegative↗ source
  • Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk
    Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Gellert Global Group recalls ALDI Fusia Kimchi & Tofu Kimbap over undeclared tuna
    Gellert Global Group of Elizabeth, NJ announced a recall of 8.1-oz packages of ALDI's Fusia Asian Inspirations Kimchi & Tofu Kimbap because they may contain undeclared tuna. The undeclared fish po…
    fda recalls · 4mo agoCRLNegative↗ source
  • FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell Disease
    The U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
    fda press · 4mo agoApprovalPositive↗ source
  • Kao USA issues voluntary recall of select Oribe scalp shampoo lots over bacterial contamination
    Kao USA announced a voluntary recall of select lots of its Oribe Serene Scalp Densifying Shampoo in the United States and Canada after detecting the bacterium Pluralibacter gergoviae. The recall a…
    fda recalls · 4mo agoRegulatoryNegative↗ source
  • Eunha Fisheries recalls frozen halibut and flounder sashimi after undisclosed wheat, soy, sesame found in condiment packets
    On July 1, 2026, Eunha Fisheries Co., Ltd. of Busan, South Korea announced a recall of certain sliced Korean halibut and flounder sashimi products. The recall covers items that were sold in the Uni…
    fda recalls · 4mo agoRegulatoryNegative↗ source
  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 4mo agoApprovalPositive↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 4mo agoRegulatoryPositive↗ source
  • La Ceiba Foods recalls Salvadoran and Mexican cottage cheese over possible Listeria contamination
    La Ceiba Foods Latin Market Inc. announced on June 26, 2026 that it is recalling its Requesón Salvadoreño (Salvadoran cottage cheese) and Requesón Mexicano (Mexican cottage cheese) products sold un…
    fda recalls · 4mo agoRegulatoryNegative↗ source
  • FDA proposes rule to require foreign tobacco makers to register and list products, aiming to curb illegal imports and protect youth
    The U.S. Food and Drug Administration announced on June 26, 2026 a proposed rule intended to strengthen its ability to identify illegal foreign tobacco products, including youth‑appealing e‑cigaret…
    fda press · 4mo agoRegulatoryPositive↗ source
  • FDA approves first generic single-dose baloxavir tablet for flu treatment and prevention
    FDA announced approval of the first generic version of Xofluza (baloxavir marboxil) tablets, a single-dose treatment for acute uncomplicated influenza and prophylaxis for patients five years of age…
    fda press · 4mo agoApprovalPositive↗ source
  • FDA approves OTC naloxone nasal spray Rextovy, expanding consumer access to overdose treatment
    The FDA announced approval of a new over-the-counter naloxone nasal spray called Rextovy, delivering 4 mg of naloxone hydrochloride for emergency reversal of opioid overdose. The product can be pu…
    fda press · 5mo agoApprovalPositive↗ source
  • FDA grants accelerated approval for Tzield to delay insulin loss in children with newly diagnosed Stage 3 type 1 diabetes
    The U.S. Food and Drug Administration issued an accelerated approval on June 12, 2026 for Tzield (teplizumab) to slow the decline of insulin production in pediatric patients aged 8 to 17 who have r…
    fda press · 5mo agoApprovalPositive↗ source
  • FDA clears Dexcom's Stelo as first OTC continuous glucose monitor for children
    The U.S. Food and Drug Administration cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in children two years of age and older who do not use insulin. This is the first OTC…
    fda press · 5mo agoApprovalPositive↗ source
  • FDA grants emergency use authorization for generic Nitenpyram tablets to treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for generic Nitenpyram tablets to treat New World screwworm infestations in dogs, puppies, cats and kittens that weig…
    fda press · 5mo agoRegulatoryPositive↗ source
  • FDA adds bemotrizinol, first new sunscreen ingredient in 20 years
    The U.S. Food and Drug Administration has approved bemotrizinol as a new active ingredient for over‑the‑counter sunscreens, marking the first addition to the sunscreen monograph since the late 1990…
    fda press · 5mo agoRegulatoryPositive↗ source
  • FDA releases draft guidance to speed cell and gene therapy approvals
    The FDA announced a draft guidance aimed at helping developers bring gene therapies to patients more quickly. It encourages use of publicly available scientific data and existing platform knowledge…
    fda press · 5mo agoRegulatoryNeutral↗ source
  • FDA releases draft guidance to trim animal testing in cancer drug development
    The FDA's Oncology Center of Excellence announced a draft guidance aimed at reducing unnecessary animal studies in the nonclinical safety assessment of certain oncology drugs. The guidance suggest…
    fda press · 5mo agoRegulatoryPositive↗ source