FDA•MODERATE
Pedigree High Protein Chopped Ground Dinner
Mars Petcare is recalling Pedigree High Protein Chopped Ground Dinner over potential contamination with plastic and metal foreign material.
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FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets over N-nitroso impurity above safe limit.
3 products
FDA•MODERATEDextroamphetamine/Amphetamine Extended-Release CapsulesLannett is recalling 5 mg Dextroamphetamine/Amphetamine ER capsules due to a labeling mix-up where capsules contain immediate-release pellets.
FDA•MODERATEAsclemed: Multiple Lidocaine Hcl Injection ProductsAsclemed recalls Accucaine kits and Lidocaine HCl injection ampules over sterility concerns.
2 products
FDA•MODERATEA.T.S. 4000 TS Tourniquet Dual HoseZimmer Surgical recalls A.T.S. 4000 TS Tourniquet Dual Hoses over sterility breach risk.
2 products
FDA•MODERATEGore TAG Thoracic Branch Endoprosthesis Side Branch ComponentGore is recalling 30+ models of the TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation.
2 products
FDA•MODERATEBard Acute Drainage TraysBard recalls Acute Drainage trays due to deficient lidocaine ampoules from supplier.
20 products
FDA•MODERATEMedline Gravity SetMedline is recalling gravity sets labeled "Not for Human Use" that were inadvertently shipped to the U.S. market.
FDA•MODERATESolar GI System Water PerfusionLaborie is recalling Solar GI System configurations due to moisture accumulation that may affect pressure measurement performance.
FDA•MODERATECovidien Shiley Disposable Decannulation PlugCovidien is recalling 12+ models of Shiley Disposable Decannulation Plugs due to incorrect labeling regarding DEHP content.
2 products
FDA•MODERATEGlucagon Emergency KitLupin recalls Glucagon Emergency Kits due to a stability test failure that may impair emergency use.
3 products
FDA•MODERATEProvision Health: 2 productsPH Labs recalls Ocular Plus and Vista MAX supplements for undeclared Yellow #5 allergen.
2 products
FDA•MODERATEGemcitabine InjectionHikma is recalling Gemcitabine Injection due to improper temperature storage.
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.
- Device RecallFDA•MODERATERayCare 2024A SP1 Oncology Information Systems
RaySearch recalls RayCare 2024A SP1 over beam set delivery note data loss risk.
2 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 detector lift movement.
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 Dilatation BalloonBoston Scientific recalls CRE Pro Wireguided Dilatation Balloons over 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•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 for undeclared Yellow #5.
2 products
FDA•MODERATEOribe Serene Scalp Densifying ShampooKao USA is recalling Oribe Serene Scalp Densifying Shampoo due to microbial contamination from Pluralibacter gergoviae.
FDA•MODERATEMedline Arterial Access TraysMedline recalls arterial access kits with Huons lidocaine ampules over quality issues.
19 products
FDA•MODERATEATTUNE Revision Hinge Knee Hinge Housing ComponentsDepuy Synthes recalls ATTUNE Revision Hinge Knee Hinge Housing Components due to packaging adhesion that may compromise sterility.
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•MODERATEBlue Ribbon Classics French Vanilla Ice CreamWells Enterprises is recalling 1-gallon pails of Blue Ribbon Classics French Vanilla ice cream due to elevated coliform levels.
3 products
FDA•MODERATEMedline Convenience Kits with Swan-Ganz CathetersMedline recalls convenience kits with Swan-Ganz catheters over leak/breakage 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•MODERATEBakr Brown Butter Chocolate Chunk Cookie DoughBakr Brown Butter Chocolate Chunk Cookie Dough is recalled due to an undeclared soy allergen.
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 PumpBoston Scientific recalls Intera 3000 pump over drug pathway leakage risk.
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline recalls convenience kits with 10mL syringes over unapproved design changes.
23 products
FDA•MODERATEPediatric Total Parenteral Nutrition BagCentral Admixture Pharmacy Services is recalling a pediatric TPN bag due to an incorrect formulation missing copper and famotidine.
FDA•MODERATEPerampanel CIII TabletsSun Pharmaceutical is recalling 6mg Perampanel CIII tablets due to a labeling mix-up where bottles may contain 10mg tablets.
FDA•MODERATELacosamide 100mg TabletsCamber Pharmaceuticals is recalling Lacosamide 100mg tablets due to a potential mix-up with Selexipag 1000 mcg tablets.
2 products
FDA•MODERATEEl David Gelee Bonbons with FruitsAlb-USA is recalling El David Gelee Bonbons with Fruits due to undeclared FD&C Yellow 5 and FD&C Red 40.
FDA•MODERATEPhilips Telemetry Monitor 5500Philips is recalling Telemetry Monitor 5500 units due to a potential reset error that prevents connection to the central monitoring system.
FDA•MODERATEPersona Revision Femoral Distal AugmentZimmer is recalling the Persona Revision Femoral Distal Augment (model 42-5572-066-10) due to a packaging error.
- Device RecallFDA•MODERATEThuvera Laser Console
IPG Medical is recalling the Thuvera Laser Console due to a software anomaly that may cause a false error code 5018 display.
FDA•MODERATEGE Healthcare AW Server 3.2 ext.6.5GE Healthcare is recalling the AW Server 3.2 ext.6.5 image processing system due to a software error that may display the wrong patient's data.
FDA•MODERATEPReye Vitamin See Antioxidant Eye DropsPReye is recalling Vitamin See Antioxidant Preservative Free Eye Drops due to a lack of assurance of sterility.