FDA•CRITICAL
Abiomed Automated Impella Controller
Abiomed is recalling the Automated Impella Controller due to hardware issues that may cause motor control, startup, or power failures.
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FDA•CRITICALBolton Medical Thoracic Stent-Graft Delivery SystemBolton Medical Inc. is recalling its Thoracic Stent-Graft delivery system due to a labeling update concerning disconnection of the proximal clasp from the outer control tube, which may prevent release of the stent-graft from the delivery system.
2 products
FDA•CRITICALWhole Foods Market Kitchens Minestrone SoupWhole Foods Market Kitchens Minestrone Soup is recalled due to an undeclared shrimp allergen.
FDA•MODERATEFentanyl Citrate Sterile CADD for InjectionIntegraDose is recalling Fentanyl Citrate Sterile CADD for Injection (NDC 71139-6030-1) due to the product being subpotent.
FDA•MODERATENephronex Vitamin B-Complex, Vitamin C & Folic Acid LiquidSafecor Health is recalling Nephronex dietary supplement liquid due to the presence of foreign black particles.
FDA•CRITICALSolina U.S. Holding: 10 productsSolina recalls multiple seasonings over potential Salmonella contamination.
10 products
FDA•CRITICALFontana Flavors: 3 For Further Processing WisFontana Flavors recalls 3 flavor products (white cheddar, cream of mushroom, parmesan) over possible Salmonella.
3 products
FDA•MODERATEPhilips Azurion Image Guided Therapy SystemsPhilips is recalling various Azurion systems due to potential mechanical wear in the Float Tabletop control module affecting table movement.
2 products
FDA•MODERATEPhilips Azurion X-ray Tube Cooling Unit Deaeration HosePhilips recalls Azurion systems: deaeration hose may leak oil, causing cooling failure and low-dose fluoroscopy lockout.
4 products
FDA•MODERATESilastic Foley CathetersC.R. Bard is recalling Silastic Brand Foley Catheters due to surface staining on the devices.
FDA•CRITICALBirch Benders Sweet Potato Pancake and Waffle MixBirch Benders Sweet Potato Pancake and Waffle Mix recalled over undeclared egg.
FDA•MODERATEEstradiol Gel 0.1%ANI Pharmaceuticals is recalling Estradiol Gel 0.1% due to defective packets that may be empty or partially full.
FDA•MODERATECimzia Prefilled SyringesUCB is recalling Cimzia prefilled syringes and starter kits due to a lack of assurance of sterility.
FDA•MODERATEErythromycin Tablets 250 mgZydus recalls Erythromycin 250 mg tablets due to impurity above acceptable limit.
2 products
FDA•MODERATEGlobus Medical OneLIF Integrated FixationGlobus Medical is recalling OneLIF integrated fixation systems because some units may not meet shelf-life specifications, which could affect product performance.
2 products
FDA•MODERATEMedtronic GUNDRY Retrograde CannulaMedtronic recalls GUNDRY Retrograde Cannula over sterile barrier breach risk.
9 products
FDA•MODERATEVitamin B-Complex, Vitamin C & Folic Acid SupplementLlorens Pharmaceuticals is recalling Vitamin B-Complex, Vitamin C & Folic Acid supplement bottles due to foreign black particulate matter.
FDA•MODERATEAllProvide Gently Cooked Chicken Recipe for DogsAllProvide is recalling 16 oz Gently Cooked Chicken Recipe for Dogs due to potential plastic contamination.
FDA•MODERATEGas-X Simethicone 125 mg SoftGelsHaleon is recalling Gas-X Simethicone 125 mg SoftGels (120 count), UPC 3 00674 35041 9, due to incomplete inactive ingredient labeling.
FDA•MODERATEWellnov Supplements: 14 Vitaminally LLC Chandler AzesWellnov recalls liquid multivitamins and supplements over cGMP deviations risking bacterial contamination and C. botulinum.
14 products
FDA•MODERATELiraglutide InjectionLupin is recalling Liraglutide Injection (NDC 70748-346-02 and 70748-346-03) due to white thread-like particulate matter in the cartridge.
FDA•CRITICALMalazi Pure Sudanese Sesame TahinaMalazi 100% Pure Sudanese Sesame Tahina is being recalled due to potential Salmonella contamination.
FDA•MODERATEAtomoxetine HCl CapsulesSafecor Health is recalling Atomoxetine HCl capsules due to a labeling mix-up that may result in patients receiving an incorrect dosage.
FDA•LOWPrimidone Tablets 250 mgAmerican Health Packaging recalls Primidone Tablets 250 mg due to trace Acemetacin contamination.
2 products
FDA•LOWBusulfan InjectionSagent Pharmaceuticals is recalling Busulfan Injection (NDC 25021-241-10) due to failed impurities and degradation specifications.
FDA•LOWPrimidone Tablets 50 mgPrimidone 50 mg tablets recalled due to possible cross-contamination with Acemetacin.
2 products
FDA•LOWPrimidone 250mg TabletsLannett Company is recalling Primidone 250mg Tablets (NDC 0527-1231-01) due to potential cross-contamination with Acemetacin API.
FDA•MODERATEICU Medical Oncology Extension SetICU Medical is recalling Oncology Extension Set REF: CL3960 due to a potential leak that could cause therapy interruption or hazardous exposure.
FDA•CRITICALKroger Homestyle Cheese and Garlic CroutonsKroger Homestyle Cheese and Garlic Croutons recalled over possible Salmonella from milk powder.
FDA•CRITICALPS Seasoning & Spices: 6 productsPS Seasoning recalls Ellsworth Sour Cream + Onion Seasoning and other seasonings over Salmonella risk.
6 products
FDA•MODERATEOphthavet Ophthalmic SolutionDechra is recalling Ophthavet Ophthalmic Solution for dogs and cats due to a lack of sterility assurance.
FDA•MODERATETangent Single Use Digital CatheterTangent Endoscopy is recalling single-use digital catheters due to potential fractures at the distal shaft tip.
FDA•MODERATESwan-Ganz Catheters (Multiple Models)Becton, Dickinson and Company is recalling multiple variants of its Swan-Ganz pulmonary artery catheters due to a potential risk of valve leakage that may affect the balloon inflation performance.
3 products
FDA•MODERATEStraus Family Creamery: 5 productsStraus Family Creamery recalls Organic Super Premium Ice Cream over possible metal pieces.
5 products
FDA•MODERATEProspector Popcorn Belgian Chocolate Toffee PopcornProspector Popcorn Belgian Chocolate Toffee recalled for undeclared soy (soy lecithin).
2 products
FDA•MODERATELVIS Intraluminal Support DeviceMicroVention recalls LVIS Intraluminal Support Devices (REF 214022-CAS, 214518-CAS, 213517-CAS) due to dimensional nonconformance risking vessel injury or thrombosis.
- Device RecallFDA•MODERATEMedtronic SynchroMed Flex Infusion Mode A810 Software
Medtronic is recalling A810 software for SynchroMed pumps due to a display error that may cause incorrect or missed medication delivery.
2 products 
FDA•CRITICALDOXOrubicin Hydrochloride Liposome InjectionSun Pharma recalls DOXOrubicin Liposome Injection 50 mg/25 mL vials due to glass particulate matter.
FDA•CRITICALHellas Meze Golden Smoked Whole HerringTerra Medi is recalling Hellas Meze Golden Smoked Whole Herring due to potential Clostridium botulinum contamination.
FDA•CRITICALEnoki MushroomsIQ Produce is recalling 150g Enoki Mushrooms due to potential Listeria monocytogenes contamination.
FDA•CRITICALEnoki MushroomsHH Fresh Trading is recalling 150g packages of Enoki Mushrooms due to potential Listeria monocytogenes contamination.
FDA•MODERATERaja Foods and Vegetables: 2 Flavored Masala CandiesRaja Foods recalls Swad Orange and Mango Masala Candies due to undeclared FD&C Yellow 6.
2 products
FDA•MODERATECodman CerebroFlo EVD CatheterIntegra LifeSciences is recalling the Codman CerebroFlo EVD Catheter due to out-of-specification endotoxin results.
FDA•CRITICALArrow Edge Hemodialysis Catheterization ProductArrow Edge hemodialysis catheterization product recalled: sheath introducer may not split, risking injury.
6 products
FDA•CRITICALOmnicell i.v.STATION Syringe LabelsOmnicell is recalling sterile syringe label stock for the i.v.STATION device due to a risk of mislabeled IV medication syringes.
FDA•MODERATEBARD Dynamic Deca Steerable CatheterBARD Dynamic Deca Steerable EP catheter recalled due to incomplete seals on sterile product.
26 products
FDA•MODERATEEdwards EVOQUE Tricuspid Delivery SystemEdwards Lifesciences is updating the labeling for the EVOQUE tricuspid delivery system to include a warning about potential functionality issues.
FDA•MODERATECreamy Sesame NoodlesFly By Jing recalls Creamy Sesame Noodles over possible undeclared peanut allergen.
FDA•MODERATEZYMUTEST HIA IgG ELISA KitZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.
FDA•MODERATEPhilips Azurion Cable Hose CarrierPhilips is recalling Azurion imaging systems due to potential loosening or breakage of Cable Hose Carrier bolts and plastic parts.