Tag: fda
-
Par Health Recalls Two Lots of Brevital Sodium Over Particulate Matter
Par Health is recalling two lots of Brevital Sodium 500 mg/vial to the hospital level after cellulose particulate matter was found, with a risk of life-threatening adverse health consequences.
HealthBusinessLaw EnforcementUSAMedical ScienceLegalSocial Issues Product RecallPar HealthBrevital SodiumMethohexital SodiumUS Food and Drug AdministrationParticulate MatterMedWatchFood RecallsFDADrugs
-
FDA Early Alert: Philips Lumify Ultrasound Software Issue Linked to Four Deaths
Philips Ultrasound warns that a Lumify app software issue can force unexpected transducer re-registration, blocking scans in pre-hospital settings. Eight serious injuries and four deaths reported.
HealthScience & TechnologyLaw EnforcementUSAMedical ScienceComputers and InternetLegalFederal Government Philips UltrasoundLumifyDiagnostic Ultrasound SystemFDAMedical Device RecallProduct RecallPatient SafetyFood RecallsDrugs
-
Leader Formulas Recalls RAPTURE Preworkout Nationwide Over DMAA
The Tomball, Texas, company is voluntarily recalling one lot of the supplement powder after FDA testing found DMAA, which can raise blood pressure and cause cardiovascular problems.
HealthBusinessLaw EnforcementUSAMedical ScienceLegalSocial IssuesFederal Government Product RecallLeader FormulasRAPTURE PreworkoutDMAAUS Food and Drug AdministrationMedWatchDietary SupplementFood RecallsFDADrugsLeader Formulas LLCTomball Texas
-
Pacific Health Sciences Recalls One Lot of Babies' Magic Tea Baby Sleep Gripe Water Over Undeclared Alcohols
FDA testing found undeclared ethanol, methanol and isopropanol in Lot 25122bw, and parents and caregivers are told to stop using it.
HealthBusinessLaw EnforcementUSAMedical ScienceLegalSocial IssuesFederal Government Product RecallPacific Health SciencesBabies' Magic TeaBaby Sleep Gripe WaterFDAMedWatchDietary SupplementFood RecallsDrugsUS Food and Drug Administrationethanolmethanol
-
Nova Biomedical Issues Global Correction for StatStrip Glucose Hospital Meter Over Patient Mix-Up Risk
Nova Biomedical's global Medical Device Correction for the Gen 2.0 StatStrip Glucose Hospital Meter follows a software flaw that may link glucose results to the wrong patient.
HealthBusinessScience & TechnologyMedical ScienceLaw EnforcementLegal Nova BiomedicalStatStrip Glucose Hospital MeterMedical Device CorrectionProduct RecallUS Food and Drug AdministrationGlucose MonitoringPatient SafetyFood RecallsFDADrugs
-
FDA Updates BD Alaris Infusion Set Recall, Warns of Worse Pump Performance
BD and CareFusion issue an updated letter warning that some BD Alaris Pump Infusion Sets perform worse than previously disclosed, with deviations at low rates and bolus volumes.
HealthBusinessScience & TechnologyUSAMedical ScienceLaw EnforcementFederal Government Product RecallBD Alaris Pump Infusion SetsCareFusion 303BD Alaris Pump Module 8100US Food and Drug AdministrationMedical Device RecallsGuardrails Suite MXFood RecallsFDADrugs
-
FDA: ICU Medical Drops Enhanced Inspection Advice for IV Tubing Sets After Discoloration Probe
ICU Medical has ended its recommended enhanced inspections of certain IV tubing sets after finding black specks and discoloration in drip chambers are intrinsic to the PVC material and pose no patient risk.
HealthBusinessUSAMedical ScienceLaw EnforcementSocial Issues ICU MedicalIV tubing setsdrip chambersFDAMedical Device RecallsProduct Recallpatient safetyFood RecallsDrugs
-
Flowers Foods Recalls Nature's Own Hawaiian Bread Over Undeclared Milk
Flowers Foods is recalling Nature's Own Hawaiian Bread in 20 oz. and 40 oz. bags sold in five states because milk was not declared as an ingredient on the packaging.
HealthBusinessUSALaw Enforcement Product RecallFlowers FoodsNature's Own Hawaiian Breadundeclared milkUS Food and Drug Administrationmilk allergyArkansasFood RecallsFDADrugs
-
Saint Francis Apizza Recalls Frozen Pizzas Over Undeclared Soy Allergen
Saint Francis Apizza LLC voluntarily recalled frozen pizzas in four varieties sold across Cincinnati, Dayton and northern Kentucky because soy was not declared on the label.
HealthBusinessLaw EnforcementUSALegalSocial Issues Product RecallSaint Francis Apizza LLCSoy allergenFrozen pizzasUS Food and Drug AdministrationCincinnatiFood safetyFood RecallsFDADrugs
-
EAK Distribution Recalls Home Grown Calabrese Broccoli Seeds Over Salmonella Risk
EAK Distribution of Casper, Wyoming, is recalling 8 oz Home Grown Green Sprouting Calabrese Broccoli Seeds sold on Amazon nationwide because of possible Salmonella contamination. No illnesses reported.
HealthBusinessUSALaw EnforcementAgricultureSocial Issues Product RecallEAK Distribution LLCSalmonellaBroccoli SeedsUS Food and Drug AdministrationCasper, WyomingAmazon.comFood RecallsFDADrugs
-
WinCo Foods Recalls Salsa Bean Dip Trays Over Recalled Peperoncini
WinCo Foods of Boise, Idaho is recalling two Salsa Bean Dip Tray products sold in eight states after a recalled lot of G.L. Mezzetta peperoncini was used as an ingredient.
HealthBusinessLaw EnforcementUSAGeneral PoliticsFederal GovernmentAgriculture Product RecallWinCo FoodsG.L. MezzettaSalsa Bean Dip TraysPeperonciniUS Food and Drug AdministrationBoise, IdahoFood RecallsFDADrugs
-
Stewart's Shops Recalls Two Half-Gallon Ice Cream Flavors Over Possible Metal
Stewart's Shops Corp. of Saratoga Springs, NY recalls Heavenly Medley and Vanilla-Chocolate-Strawberry half-gallon ice cream sold in New York, Vermont and New Hampshire due to potential metal presence.
HealthBusinessLaw EnforcementUSALegalSocial Issues Product RecallStewart's Shops Corp.US Food and Drug AdministrationIce creamSaratoga SpringsForeign objectNew YorkFood RecallsFDADrugs
-
Chilean Supplier Expands Frozen Berry Recall Over E. coli O145 Risk
Frutas y Hortalizas del Sur S.A. expands its frozen organic berry recall to more Great Value lots and a Trader Joe's lot over potential E. coli O145 contamination.
HealthBusinessLaw EnforcementUSAChileMedical ScienceAgricultureSocial Issues Product RecallE. coli O145Frutas y Hortalizas del Sur S.A.Great Value frozen organic berriesTrader Joe's frozen organic mixed berry blendUS Food and Drug AdministrationHemolytic uremic syndromeFood RecallsFDADrugs
-
Gias Foods Recalls bettergoods Lemon Alfredo Fettuccine Over Listeria Risk
Gias Foods of New York is recalling all lot codes of bettergoods Authentic Italian Lemon Alfredo Fettuccine sold nationwide at Walmart over possible Listeria monocytogenes contamination. No illnesses reported.
HealthBusinessUSALaw EnforcementSocial Issues Product RecallGias Foodsbettergoods Authentic Italian Lemon Alfredo FettuccineListeria monocytogenesWalmartUS Food and Drug AdministrationNew YorkFood RecallsFDADrugs
-
Greenwich Rx Recalls Compounded Glutathione Nationwide Over Elevated Endotoxin Levels
Greenwich Rx, a 503A compounding pharmacy in Tomball, Texas, is voluntarily recalling specific lots of compounded glutathione to the consumer level over potential elevated endotoxin levels.
HealthBusinessLaw EnforcementMedical ScienceLegal Greenwich RxProduct RecallGlutathioneEndotoxinUS Food and Drug AdministrationCompounding PharmacyTomball, TexasFood RecallsFDADrugs
-
Greenwich Rx Recalls Compounded Glutathione Nationwide Over Elevated Endotoxin Levels
Greenwich Rx is recalling specific lots of compounded glutathione nationwide after two patients needed emergency care following IV use of a product not formulated for IV administration.
HealthBusinessLaw EnforcementMedical ScienceLegalSocial Issues Product RecallGreenwich RxCompounded GlutathioneEndotoxinUS Food and Drug AdministrationMedWatchSubcutaneous InjectionFood RecallsFDADrugs
-
Sierra Nevada Cheese Company Recalls All Graziers Raw Milk Cheese Over E. coli Risk
California-based Sierra Nevada Cheese Company is voluntarily recalling all Graziers Raw Milk Cheese sold nationwide after potential contamination with Shiga toxin-producing E. coli O26:H11 was identified.
HealthBusinessUSALaw EnforcementSocial Issues Product RecallSierra Nevada Cheese CompanyGraziers Raw Milk CheeseE. coli O26:H11Shiga toxin-producing Escherichia coliHemolytic Uremic SyndromeUS Food and Drug AdministrationFood RecallsFDADrugs
-
Mezzetta Recalls Golden Greek Peperoncini Over Pest Contaminant in Jar
G. L. Mezzetta Inc. voluntarily recalls a specific lot of 32-ounce Mezzetta Golden Greek Peperoncini Medium Heat after a social media video showed a potential pest contaminant in a jar.
HealthBusinessLaw EnforcementUSAGeneral PoliticsSocial Issues Product RecallG. L. Mezzetta Inc.Mezzetta Golden Greek PeperonciniUS Food and Drug AdministrationPest ContaminantFood SafetyFood RecallsFDADrugs
-
Galil Importing Corp Recalls Lior Cinnamon Ground Seasoning Over Elevated Lead Levels
Galil Importing Corp of Hauppauge, New York is recalling Lior Cinnamon Ground Seasoning over potential elevated lead contamination. The product was sold in seven states; no illnesses reported.
HealthBusinessLaw EnforcementUSAGeneral PoliticsLegalSocial Issues Product RecallGalil Importing CorpLior Cinnamon Ground SeasoningLead contaminationUS Food and Drug AdministrationHauppauge, New YorkFood RecallsFDADrugs
-
Deano's Pasta Recalls Pear and Pecorino Triangoli Ravioli Over Undeclared Lobster
Deano's Pasta of Somerville, MA is recalling about 20 lbs. of frozen Pear and Pecorino Triangoli Ravioli sold in Massachusetts because it may contain undeclared lobster, an allergen.
HealthBusinessLaw EnforcementUSALegalSocial Issues Product RecallDeano's PastaPear and Pecorino Triangoli RavioliUndeclared LobsterCrustacean Shellfish AllergySomerville, MassachusettsUS Food and Drug AdministrationFood RecallsFDADrugs
-
Berlin Seeds Recalls 950 lbs of Alfalfa Sprouting Seed Over E. coli and Salmonella Risk
Berlin Seeds of Millersburg, Ohio, is recalling 950 lbs of Alfalfa Sprouting Seed sold in 43 states and online between February and August 2026 after one illness was reported.
HealthBusinessUSALaw EnforcementAgricultureSocial Issues Product RecallBerlin SeedsAlfalfa Sprouting SeedShiga toxin-producing Escherichia coliSalmonellaUS Food and Drug AdministrationMillersburg, OhioFood RecallsFDADrugs
-
FDA Issues Early Alert on React Health VOCSN Ventilator Reboot Risk
React Health warns customers of a possible unseated cable connector in VOCSN ventilators that can cause reboots and System Fault 10 alarms, interrupting ventilation therapy.
HealthScience & TechnologyBusinessUSAMedical ScienceFederal GovernmentLaw Enforcement FDAReact HealthVentec Life Systems Inc.VOCSN ventilatorMedical Device RecallSystem Fault 10Internal Flow TransducerFood RecallsDrugs
-
Wakefern Recalls Wholesome Pantry Organic Apple Sauce Over Elevated Patulin Levels
Wakefern Food Corp. voluntarily recalled 23-ounce jars of Wholesome Pantry Organic Unsweetened Apple Sauce after FDA testing found elevated patulin levels exceeding food safety limits. No illnesses have been reported.
HealthBusinessLaw EnforcementUSAGeneral PoliticsFederal GovernmentAgriculture Product RecallWakefern Food Corp.Wholesome Pantry Organic Unsweetened Apple SaucePatulinUS Food and Drug AdministrationShopRiteKeasbey, New JerseyFood RecallsFDADrugs
-
FDA Issues Early Alert on Abiomed Heart Pump Controller Quality Issues
Abiomed has told customers to remove certain Automated Impella Controllers from use or sale over hardware, firmware and software quality issues, though hospital inventory can still be used.
HealthBusinessScience & TechnologyUSAMedical ScienceLaw EnforcementSocial Issues FDAAbiomedAutomated Impella ControllerMedical Device RecallHeart PumpProduct RecallPatient SafetyFood RecallsDrugs
-
Otsuka ICU Medical Recalls Sodium Chloride Injection Lot Over Potassium Chloride Mix-Up
Otsuka ICU Medical LLC voluntarily recalls one lot of 0.9% Sodium Chloride Injection nationwide after a customer found a highly concentrated potassium chloride bag inside the overwrap.
HealthBusinessLaw EnforcementMedical ScienceLegal Product RecallOtsuka ICU Medical LLCSodium Chloride InjectionPotassium Chloride InjectionUS Food and Drug AdministrationAustin, TXCardiac ArrestFood RecallsFDADrugs
-
Par Health Recalls Two Lots of Dexmedetomidine Injection Over Particulate Matter
Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection to the hospital level after cellulose or stopper material was found in the product.
HealthBusinessLaw EnforcementMedical ScienceLegal Product RecallPar HealthDexmedetomidine HClSodium Chloride InjectionUS Food and Drug AdministrationParticulate MatterPulmonary EmboliFood RecallsFDADrugs
-
Global Mix Inc. Recalls Niwali Tejocote Capsules and Pieces Over Possible Yellow Oleander Contamination
Global Mix Inc. of Middle Village, New York, is recalling niwali Tejocote Capsules and Pieces after FDA analysis found the products appear to be yellow oleander, a highly toxic plant.
HealthBusinessLaw EnforcementUSAMedical ScienceSocial Issues Product RecallGlobal Mix Inc.niwali Tejocote Capsulesyellow oleanderThevetia peruvianaUS Food and Drug AdministrationMiddle Village, New YorkFood RecallsFDADrugs
-
GF Blends Recalls Flour and Pizza Mix Over Undeclared Wheat Gluten
GF Blends is recalling Truly AIP All Purpose Flour and Bread Mix and EAT G.A.N.G.S.T.E.R. Flat Bread Pizza Mix after testing found gluten levels far above the FDA's 20 ppm limit.
HealthBusinessLaw EnforcementUSAGeneral PoliticsLegalSocial Issues GF BlendsProduct RecallUndeclared Wheat GlutenTruly AIP All Purpose Flour and Bread MixEAT G.A.N.G.S.T.E.R. Flat Bread Pizza MixPMF GlobalUS Food and Drug AdministrationFood RecallsFDADrugs
-
Gias Foods Recalls bettergoods Lemon Alfredo Fettuccine Over Listeria Risk
Gias Foods of New York is recalling two lots of frozen bettergoods Authentic Italian Lemon Alfredo Fettuccine sold nationwide at Walmart over possible Listeria monocytogenes contamination. No illnesses reported.
HealthBusinessUSALaw EnforcementMedical ScienceSocial Issues Product RecallGias Foodsbettergoods Authentic Italian Lemon Alfredo FettuccineListeria monocytogenesWalmartUS Food and Drug AdministrationNew YorkFood RecallsFDADrugs
-
Media Monitor: TIME Health Reports on Drinking Trends, AI in Medicine, and FDA Animal Testing Rules
TIME Health reports older Americans are drinking more even as overall U.S. alcohol use hits record lows, and offers guidance on using AI safely alongside doctor visits.
HealthScience & TechnologyPolitics and GovernmentUSAArtificial IntelligenceMedical ScienceFederal GovernmentEnvironmentClimate Change TIMEalcohol consumptionGallup pollhealth careFDAanimal testingTIME Health