FDA•CRITICAL
Magnesium Sulfate in Water for Injection IV Bag
Amneal is recalling Magnesium Sulfate IV bags (NDC 70121-1720-3) due to product mix-up with Tranexamic Acid.
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FDA•MODERATEDiversatek Healthcare Viper 3-Stage Fixed Wire Balloon DilatorDiversatek Healthcare is recalling the Viper 3-Stage Fixed Wire Balloon Dilator due to incorrect labeling of balloon sizes and pressures.
4 products
FDA•MODERATEBromfenac Ophthalmic Solution 0.07%Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.07% (NDC 62332-583-03) due to failed impurities and degradation specifications.
FDA•LOWRemedy Gel Hydrocortisone 1%Island Kinetics is recalling Remedy Gel hydrocortisone 1% due to subpotency.
3 products
FDA•MODERATEDimension Creatinine Flex Reagent CartridgeSiemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.
FDA•MODERATEOctreotide Acetate for Injectable SuspensionTeva is recalling Octreotide Acetate for Injectable Suspension due to a lack of assurance of sterility.
6 products
FDA•MODERATECurosurf (poractant alfa) 240 mg Intratracheal SuspensionChiesi USA is recalling Curosurf 240 mg intratracheal suspension vials (NDC 10122-510-03) due to lack of sterility assurance.
FDA•MODERATEXanax XR Alprazolam 3 mg TabletsViatris is recalling Xanax XR 3 mg tablets (NDC 58151-506-91) due to failed dissolution specifications.
FDA•MODERATEStraumann Custom Abutment TiStraumann is recalling custom abutments manufactured with incorrect raw material.
2 products
FDA•MODERATEAlbuterol Sulfate Inhalation Solution 0.5%Nephron SC recalling Albuterol Sulfate Inhalation Solution (NDC 69374-330-05) due to illegible labeling.
FDA•CRITICALMedical Action Industries Pack Cath BHHMedical Action Industries is recalling Pack Cath BHH kits due to a defect in the syringe adapter that may cause it to disconnect during use.
FDA•MODERATELucerne 2% Cottage CheeseAlbertsons is recalling Lucerne 2% Cottage Cheese due to potential contamination with metal fragments.
FDA•LOWPopping Boba RTD Mixed Berry Hibiscus TeaPocas International is recalling Popping Boba RTD Mixed Berry Hibiscus Tea due to a packaging integrity issue.
4 products
FDA•MODERATEMeclizine Hydrochloride Tablets 12.5 mgAmerican Health Packaging is recalling Meclizine Hydrochloride 12.5 mg tablets (NDC 60687-775-65 and 60687-775-11) due to failed tablet specifications.
FDA•MODERATECinacalcet Hydrochloride TabletsCipla is recalling Cinacalcet Hydrochloride Tablets due to the presence of N-Nitroso Cinacalcet above acceptable limits.
3 products
FDA•MODERATEMedline CENTURION Circumcision KitMedline is recalling CENTURION Circumcision Kit (CIT7050F) due to one lot distributed without sterilization.
FDA•MODERATEAccess Total T4 CalibratorBeckman Coulter is recalling Access Total T4 Calibrator (Catalog No. 33805) due to negative bias causing falsely low results on DxI 600/800 instruments.
FDA•MODERATEFlamingo Funnel SmallSurgiSmoke Solutions is recalling the Flamingo Funnel Small due to a manufacturing error involving non-gamma compatible sterilization drapes.
3 products
FDA•MODERATEMedline Universal Central/Art Line Insertion KitMedline is recalling convenience kits containing non-sterile alcohol prep pads due to potential bacterial contamination.
10 products
FSIS•MODERATELa Boulangerie Turkey Pesto & Swiss Cheese PocketsLa Boulangerie Turkey Pesto & Swiss Cheese Pockets (25.4 oz, lot 04926) may contain mislabeled ham and cheese filling instead of turkey, pesto, and cheese.
FDA•CRITICALBlue Bull Extreme Male Enhancement SupplementBlue Bull Extreme Male Enhancement Supplement is recalled for containing undeclared sildenafil, an unapproved drug ingredient.
3 products
FDA•MODERATELanreotide Injection 120 mg/0.5 mLCipla is recalling Lanreotide Injection 120 mg/0.5 mL due to a lack of assurance of sterility.
2 products
FDA•MODERATENoromycin 300 LA Oxytetracycline InjectionMWI Animal Health is recalling Noromycin 300 LA oxytetracycline injection (NADA# 141-143) due to lack of assurance of sterility.
FDA•MODERATEMagellan Diagnostics LeadCare II Blood Lead Test KitsMagellan Diagnostics is recalling LeadCare II blood lead test kits due to the risk of false positive results.
4 products
FDA•CRITICALHalyard Cardiac Cath Pack Syringe AdaptorAVID Medical is recalling Cardiac Cath Pack kits due to a risk of the syringe adaptor disconnecting during use.
10 products
FDA•MODERATEBuprenorphine Hydrochloride Injection 0.3mg/mLEndo USA recalls Buprenorphine Hydrochloride Injection 0.3mg/mL vials (NDC 42023-179-05) due to particulate matter contamination.
FDA•MODERATETreasured Harvest Chilli Spanish PeanutsTreasured Harvest Chilli Spanish Peanuts are recalled due to potential glass contamination.
2 products
FDA•MODERATEFavorina Chocolate Ladybugs German-Style NougatLidl is recalling Favorina Chocolate Ladybugs (3.52 oz) due to undeclared tree nut allergen on label.
FDA•MODERATEB.R.A.H.M.S PlGF Plus KRYPTOR In Vitro Diagnostic TestB.R.A.H.M.S PlGF Plus KRYPTOR (Catalog 859075N) recalled for out-of-range quality control values that may cause falsely elevated preeclampsia risk results.
FDA•MODERATEStryker Sustainability Solution Tourniquet CuffsStryker is recalling tourniquet cuffs that may fail to maintain pressure due to a potential detachment at the welding connection.
FDA•MODERATEARTIS Pheno VE30A and VE40A Imaging SystemSiemens is recalling ARTIS Pheno VE30A and VE40A imaging systems (Model 10849000) due to unregulated dose causing unintentional low-dose radiation exposure.
FDA•MODERATEMesh Style Tip ProtectorsHealthmark Industries is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) due to a lack of FDA clearance.
FDA•CRITICALDouble Down Deer Feed ProductsProducers Cooperative Association recalls Double Down Deer Feed products (SKUs 12254, 12750, 13380, 13381) over aflatoxin contamination exceeding safe limits.
2 products
FDA•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
FDA•CRITICALOmnipod 5 PodsInsulet is recalling Omnipod 5 Pods due to a cannula tear that can cause insulin leakage, leading to dangerous under-delivery of insulin.
FDA•MODERATEiLet Bionic PancreasBeta Bionics is recalling iLet Bionic Pancreas (software 1.4.2–1.4.3) for Dexcom G7 compatibility issues that may disable glucose correction dosing.
FDA•LOWYunker Energy & Health Herbal SupplementSato Pharmaceutical is recalling Yunker Energy & Health Herbal Supplement because it does not meet label claims for Vitamin E content.
FDA•CRITICALSpray Dried Dairy PowderLone Star Dairy Products is recalling Spray Dried Dairy Powder (25 kg bags, 1 metric ton totes) due to Salmonella contamination.
FDA•MODERATETETAS Mireya Cherry Milkshake PopsicleASUKAR FOODS CORP is recalling TETAS Mireya Cherry Milkshake popsicles (UPC 83822654822) due to undeclared soy lecithin.
FDA•MODERATE0.9% Sodium Chloride Injection, USPFresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP, 250 mL bags due to a lack of assurance of sterility.
14 products
FDA•MODERATEB Braun Infusion Pump Administration SetsWindstone Medical Packaging is recalling Pre Op Kits containing B Braun IV administration sets due to potential medication backflow or priming issues.
3 products
FDA•MODERATEMedtronic Sphere-9 Cardiac Ablation CatheterMedtronic Sphere-9 Catheter (Model AFR-00001) may cause ventricular fibrillation in patients with Biotronik ICDs or CRT-Ds during radiofrequency ablation therapy.
FDA•MODERATEArrow Echogenic Introducer NeedleArrow is recalling the Echogenic Introducer Needle due to a manufacturing error involving the device's liquid adhesive.
13 products
FDA•CRITICALIntuitive SureForm 30 Gray ReloadsIntuitive Surgical is recalling SureForm 30 Gray Reloads (Ref 48230M-05, 48230M-06) due to the risk of an incomplete staple line.
FDA•CRITICALCostco Service Deli Meatloaf SeasoningGriffith Foods is recalling Costco Service Deli Meatloaf Seasoning due to potential Salmonella contamination.
3 products
FDA•MODERATEHorizon Organic Chocolate Lowfat MilkHorizon Organic is recalling chocolate lowfat milk in 8-oz cartons due to compromised package integrity.
FDA•CRITICALNuts.com Espresso Malted Milk BallsNuts.com is recalling Espresso Malted Milk Balls due to undeclared wheat and soy allergens.
FDA•MODERATEARTIS pheno and ARTIS Icono Biplane X-ray SystemSiemens is recalling ARTIS pheno and ARTIS Icono X-ray systems (Models 10849000, 11327600, 11328100, 11327700) due to erroneous dose display during patient exams.
FDA•MODERATEArjo Tenor Mobile Patient LiftArjo Tenor patient lifts (Models KHA1000 US, KHA1010 US) recalled for actuator failure risk causing sudden arm drop.
FDA•MODERATEPan de Bono Cheese BreadSouth Florida Food recalling Pan de Bono Cheese Bread (14.4 lb boxes) due to undeclared soy.