FDA•MODERATE
Curosurf (poractant alfa) 240 mg Intratracheal Suspension
Chiesi USA is recalling Curosurf 240 mg intratracheal suspension vials (NDC 10122-510-03) due to lack of sterility assurance.
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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•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•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•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•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
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•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•MODERATEHorizon Organic Chocolate Lowfat MilkHorizon Organic is recalling chocolate lowfat milk in 8-oz cartons due to compromised package integrity.
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.
FDA•MODERATEIcosapent Ethyl Capsules, 1 gramZydus Pharmaceuticals is recalling Icosapent Ethyl Capsules (NDC 70710-1592-7) due to oxidized ingredient causing red dots and melted capsules.
FDA•MODERATEnanOss 3D Advanced Bone Graft SubstituteXTANT Medical is recalling nanOss 3D bone graft substitutes due to an incorrect five-year shelf life label instead of the validated four years.
FDA•MODERATEMilestone Vacuum Bag SU Large Specimen ContainerMilestone is recalling Vacuum Bag SU Large specimen containers (Model 68409SS) due to possible reagent leakage.
FDA•MODERATELSL Healthcare Central Line Dressing KitLSL Healthcare is recalling Central Line Dressing Kits (Model 2717H) due to the inclusion of non-sterile alcohol prep pads.
6 products
FDA•MODERATEKiwi Omni Vacuum Delivery SystemClinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to a risk of device breakage during use.
FDA•MODERATESiemens ARTIS pheno X-Ray SystemSiemens is recalling the ARTIS pheno x-ray system (Model 10849000) because it may incorrectly display an x-ray dose of zero during use.
2 products
FDA•MODERATEPhilips Spectral CT on RailsPhilips Spectral CT on Rails (Model 728334) requires a software update to address gantry positioning, message display, and menu option issues.
FDA•MODERATEUvlizer Handheld UV-C Germicidal WandUvlizer UV-C germicidal wands can expose users to unsafe UV-C radiation levels above international safety guidelines.
- FDA•MODERATEUvlizer Handheld UV-C Germicidal Wand
Uvlizer UV-C germicidal wands may expose users to unsafe UVC radiation levels above international safety guidelines.
FDA•MODERATESemaglutide-Glycine-Cyanocobalamin InjectableNorthwest Compounders is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials due to lack of assurance of sterility.
FDA•MODERATECUSA Clarity C7000 ConsoleIntegra LifeSciences is recalling CUSA Clarity C7000 Console (Software 2.1.1.909) due to unresponsive touch screen.
FDA•MODERATEVegetable DumplingsJFE Franchising is recalling Vegetable Dumplings over potential glass contamination.
7 products
FDA•MODERATEBrimonidine Tartrate/Timolol Maleate Ophthalmic SolutionApotex is recalling Brimonidine Tartrate/Timolol Maleate eye drops (NDC 60505-0589-1) due to lack of sterility assurance.
FDA•MODERATECook Medical Arterial Pressure Monitoring TrayCook Medical is recalling Arterial Pressure Monitoring Trays because the labeled expiration dates exceed the device's actual shelf life.
19 products
FDA•MODERATETornier HRS Max Tuberosity Bodies and TrialsTornier is recalling mislabeled shoulder replacement components that are incompatible with the HRS Max system.