FDA•MODERATE
Gemcitabine Injection
Hikma is recalling Gemcitabine Injection due to improper temperature storage.
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FDA•MODERATEZeiss Intrabeam Spherical ApplicatorZeiss is recalling the 1.5 cm Intrabeam Spherical Applicator (REF 304534-6000-557) due to failure to meet manufacturing specifications.
FDA•MODERATESiemens ARTIS icono Ceiling SuspensionSiemens is recalling the ARTIS icono ceiling suspension (Model 11328100) because monitor attachment screws may loosen over time.
FDA•CRITICALDSAEK Pack-RX Surgical Convenience KitDSAEK Pack-RX kits recalled due to contaminated alcohol prep pads; stop use and contact firm.
4 products
FDA•MODERATERayCare 2024A SP1 Oncology Information SystemsRaySearch recalls RayCare 2024A SP1 oncology software due to potential data loss in beam set delivery notes.
2 products
FDA•CRITICALHillrom Volara System Patient Circuit KitBaxter recalls Hillrom Volara P.CIRCUIT KIT (REF M08085) due to nebulizer cup leakage causing oxygen drop and ineffective treatment.
4 products- Device RecallFDA•MODERATEMedela ENFit Enteral Extension Set
Medela is recalling ENFit Enteral Extension Sets due to incorrect connectors that may cause delivery delays or misconnections.
FDA•MODERATEAccuray Cyberknife Xchange Robotic Collimator ChangerAccuray is recalling the Xchange Robotic Collimator Changer for the Cyberknife system due to a risk of the collimator falling from its housing.
FDA•MODERATEARTIS icono biplaneSiemens recalls ARTIS icono biplane over potential loss of movement after detector lift height adjustment.
3 products
FDA•MODERATEAccuray Cyberknife Xchange Robotic Collimator ChangerAccuray is recalling the Cyberknife Xchange Robotic Collimator Changer due to a risk of the component falling from its housing.
FDA•MODERATECRE Pro Wireguided DilatorBoston Scientific recalls CRE Pro Wireguided dilator due to potential sterile pouch breach.
12 products
FDA•MODERATEIntelliCuff Portable Cuff Pressure ControllerThe IntelliCuff pressure controller may fail to maintain cuff pressure due to a system leakage error, causing the motor to run continuously.
FDA•MODERATEPilling Wecksorb NeurospongesTeleflex is recalling Pilling Wecksorb Neurosponges and Neurosponge Strips due to potential out-of-specification levels of endotoxins.
2 products
FDA•MODERATEBaxter Adapter for Head PositioningBaxter is recalling the Adapter for Head Positioning due to a risk of the accessory becoming loose and moving during patient positioning.
FDA•MODERATESynjardy XR TabletsBoehringer Ingelheim is recalling Synjardy XR tablets due to manufacturing deviations involving improper cleaning and sampling of production equipment.
FDA•MODERATELevothyroxine Sodium Tablets 300 mcgAccord Healthcare is recalling 300 mcg Levothyroxine Sodium Tablets due to subpotency.
FDA•MODERATEprednisoLONE Acetate Ophthalmic Suspension 1%Lupin Pharmaceuticals is recalling three sizes of prednisoLONE Acetate Ophthalmic Suspension 1% due to the presence of a foreign substance.
FDA•MODERATERemel GC Agar BaseRemel is recalling GC Agar Base plates due to a risk of reduced or no recovery of Neisseria gonorrhoeae strains.
FDA•CRITICALHamilton Medical Ventilator Coaxial Breathing CircuitHamilton Medical is recalling ventilator coaxial breathing circuits due to a risk of valve membrane adhesion and inadequate ventilation.
FDA•LOWFexofenadine Hydrochloride Tablets 180 mgOhm Laboratories is recalling 180 mg Fexofenadine Hydrochloride tablets due to failed impurities and degradation specifications.
FDA•CRITICALBosco's Blend Chicken Doggone RawDoggone Raw is recalling 2 lb and 10 lb tubs of Bosco's Blend Chicken Doggone Raw due to potential Salmonella contamination.
FDA•MODERATEImuldosa (ustekinumab-srlf) InjectionAccord BioPharma is recalling Imuldosa (ustekinumab-srlf) 130 mg/26 mL injection vials due to a lack of assurance of sterility.
FDA•MODERATELe Chef Bakery: 2 productsLe Chef Bakery recalls Mini Tiramisu and Mini Italian Pastry Assortment due to undeclared Yellow #5.
2 products
FDA•MODERATEOribe Serene Scalp Densifying ShampooOribe Serene Scalp Densifying Shampoo recalled due to microbial contamination.
FDA•MODERATEMedline Convenience Kits with LidocaineMedline recalls 3 convenience kits with Huons Lidocaine ampules due to quality issues.
19 products
FDA•MODERATEATTUNE Knee System Revision Hinge Housing ComponentsDePuy Synthes (Johnson & Johnson) is recalling the ATTUNE Knee System Revision Hinge Housing Components due to a risk of fracture.
4 products
FDA•MODERATEMedacta Shoulder System Short Monobloc Stem BroachesMedacta is recalling Short Monobloc Stem Broaches for the Shoulder System due to a risk of humerus fracture during surgery.
FDA•CRITICALLa Colonia Foods: 4 productsLa Colonia Foods is recalling Ricotta and other fresh cheeses over possible Listeria contamination.
4 products
FDA•CRITICALTNVitamins Organic Moringa Capsules and PowderTNVitamins Organic Moringa Capsules and Powder recalled due to possible Salmonella contamination.
FDA•CRITICALDiclofenac Sodium 0.1% Eye OintmentMFV Compounding Pharmacy is recalling Diclofenac Sodium 0.1% Eye Ointment due to potential Bacillus cereus contamination.
FDA•MODERATEBlue Ribbon Classics French Vanilla Ice Cream (1 gal)Wells Enterprises recalls Blue Ribbon Classics French Vanilla (1 gal) due to elevated coliforms.
3 products
FDA•MODERATEMedline Convenience Kits with Swan-Ganz CathetersMedline recalls convenience kits with BD Swan-Ganz catheters due to hub failure risk.
9 products
FDA•MODERATEMentor Luer Lok 10cc SyringesMentor is recalling a lot of 10cc Luer Lok syringes that were distributed after their expiration date.
FDA•CRITICALBreeder's Edge Foster Care GM Enriched Goat Milk FormulaRevival Animal Health is recalling Breeder's Edge Foster Care GM Enriched Goat Milk Formula due to elevated Vitamin D levels.
FDA•CRITICALHigh Valley Orchard Chocolate: 2 productsHigh Valley Orchard Chocolate Covered Raisins recalled over undeclared peanut allergen.
2 products
FDA•MODERATEBakr Brown Butter Chocolate Chunk Cookie DoughBakr Brown Butter Chocolate Chunk Cookie Dough recalled over undeclared soy allergen.
CPSC•Treatlife Smoke and Carbon Monoxide DetectorsTreatlife smoke and CO detectors are recalled because they may fail to alert users to a fire, posing a risk of injury or death.
CPSC•Amana Air Conditioners and Heat PumpsAmana air conditioners and heat pumps are recalled due to a fire and burn hazard caused by a faulty heating element.
CPSC•Honlyne LED Party FavorsHonlyne LED party favors (Model HON-302HE) are recalled due to a button cell battery ingestion hazard that can cause serious injury or death.
CPSC•Kith Children's Loungewear SetsKith is recalling children's loungewear sets due to a violation of federal flammability standards, posing a risk of serious burn injuries.
CPSC•Small Fish Montessori Busy BoardSmall Fish Montessori Busy Board (model 2512JX02) is recalled due to a magnet ingestion hazard that can cause serious injury or death.
CPSC•Raychy Children's Light SneakersRaychy children's light-up sneakers are recalled due to a serious battery ingestion hazard from accessible lithium coin batteries.
CPSC•Lomi Roll-On Waxing KitsLomi Roll-On Waxing Kits are recalled because the warmer's power cord can overheat, posing fire, burn, and shock hazards.
CPSC•MedPride Baby OilMedPride Baby Oil is recalled for lacking child-resistant packaging, posing a risk of poisoning and lung injury to young children.
CPSC•Super Off-Road Solar Power BanksSuper Off-Road 12,000 mAh Solar Wireless Power Banks are being recalled due to a burn hazard from overheating lithium-ion batteries.
CPSC•Sunderwell Youth Electric ATVsSunderwell XW-A17 youth electric ATVs are recalled for missing brake lights, which poses a crash hazard and violates federal safety standards.
FDA•MODERATEPovi-One 10% Povidone-Iodine Oral AntisepticElevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic due to sub-potency.
FDA•MODERATEIntera 3000 Hepatic Artery Infusion PumpIntera 3000 Hepatic Artery Infusion Pump recalled over potential drug pathway leakage.
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline recalls convenience kits with 10mL polycarbonate syringes due to unapproved design changes.
23 products
FDA•CRITICALAbiomed Impella CP Introducer KitAbiomed recalls Impella CP introducer kit (14 Fr x 13 cm) over thrombus risk.
4 products