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186 stories matching this filter · ← front page

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  • Khong Guan recalls glutinous rice balls with black sesame filling over possible undeclared peanuts
    Khong Guan Corporation announced a recall of certain lots of its Glutinous Rice Balls with Black Sesame Filling after discovering they may contain undeclared peanuts. The product, sold in 14.1‑oz…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA issues early alert on Resmed Astral ventilators due to electrical component failure risk
    The FDA’s Center for Devices and Radiological Health has released an early alert warning about a possible high-risk problem with certain Resmed Astral ventilators. A defective electrical component…
    fda medwatch · 1mo agoRegulatoryNegative
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Infectious Disease356
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  • FDA Grants Emergency Use Authorization for Ivermectin Liquid to Prevent New World Screwworm in Horses
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for an ivermectin oral solution intended for horses, aimed at preventing infestations by New World screwworm. The au…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Khong Guan expands recall of glutinous rice balls over possible undeclared peanuts
    Khong Guan Corporation announced an expanded recall of its Glutinous Rice Balls with Black Sesame Filling and Black & White Glutinous Rice Balls with Black Sesame Filling after discovering they may…
    fda recalls · 1mo agoCRLNegative↗ source
  • Baxter issues urgent correction for Volara breathing device circuits due to leak risk
    Baxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use. The…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Medtronic recalls Harmony delivery catheter system after tip detachment risk
    Medtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve. The FDA classified the recall as th…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networks
    The FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
    fda press · 1mo agoRegulatoryPositive↗ source
  • FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kits
    FDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile. Medline sent a letter on June 12…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • 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 · 1mo agoCRLNegative↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
    A software anomaly may cause a false battery-health value. The pump should remain plugged in at all times.
    fda medwatch · 1mo ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
    If dropped, the Ivenix pump touchscreen may become unresponsive and should be removed from use.
    fda medwatch · 1mo ago↗ source
  • Fayus Inc., dba Yusol International Foods Recalls OLA-OLA POUNDED YAM Due to Undeclared Milk Allergen
    Fayus Inc., doing business as Yusol International Foods (Sacramento, CA) is voluntarily recalling OLA-OLA POUNDED YAM because the product may contain undeclared milk in the form of sodium caseinate…
    fda recalls · 1mo ago↗ source
  • Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
    Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
    fda medwatch · 1mo ago↗ source
  • Frutas y Hortalizas del Sur S.A. Initiates Recall of Frozen GreenWise Organic IQF Blueberries Due to Potential E. coli O145 Contamination
    July 3, 2026 – Frutas y Hortalizas del Sur S.A., San Carlos, Chile is recalling frozen GreenWise Organic IQF Blueberries 10 oz. Because it may be contaminated with Escherichia coli O145:H28 (E. col…
    fda recalls · 1mo ago↗ source
  • Voluntary Recall of Two Lots of PEDIGREE® Can High Protein Chopped Chicken & Duck Flavor Wet Dog Food Due to Potential Fraudulent Distribution of Product Which May Contain Foreign Material
    FRANKLIN, Tenn., (July 2, 2026): Mars Petcare US, Inc. is issuing a voluntary recall for two lots of PEDIGREE® Can High Protein Chopped Chicken & Duck Flavor 13.2oz for dogs.
    fda recalls · 1mo ago↗ source
  • Gellert Global Group Issues Allergy Alert on Undeclared Tuna (Fish) in Aldi Brand Fusia Asian Inspirations Kimchi and Tofu Kimbap
    Gellert Global Group of Elizabeth, NJ is recalling 8.1 oz packages of ALDI Brand Fusia Asian Inspirations Kimchi & Tofu Kimbap because they may contain undeclared fish (tuna). People who have an al…
    fda recalls · 1mo ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 1mo ago↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
    fda medwatch · 1mo ago↗ source
  • FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
    The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…
    fda press · 1mo ago↗ source
  • Kao USA Voluntarily Recalls Some Lots of Oribe Serene Scalp Densifying Shampoo
    CINCINNATI--(BUSINESS WIRE)--Kao USA Inc. (“Kao USA”) today issued a voluntary recall of select lots of its Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) in the U.S. and Canada due to…
    fda recalls · 1mo ago↗ source
  • Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products
    July 01, 2026 EUNHA FISHERIES CO., LTD., Busan, Republic of Korea, is recalling certain Sliced Korean Halibut and Flounder Sashimi products because the accompanying soy sauce and vinegar red pepper…
    fda recalls · 1mo ago↗ source
  • FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
    The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult pat…
    fda press · 1mo ago↗ source
  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 1mo ago↗ source
  • La Ceiba Foods Latin Market Inc. Recalls Cottage Cheese Products Because of Possible Health Risk
    June 26, 2026, – La Ceiba Foods Latin Market Inc. is conducting a recall of Requesón Salvadoreño (Salvadoran Cottage Cheese) and Requesón Mexicano (Mexican Cottage Cheese) products marketed under t…
    fda recalls · 1mo ago↗ source
  • FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health
    The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to e…
    fda press · 1mo ago↗ source