FDA•MODERATE
Vitek 2 AST-N447 Test Kit
Biomerieux is recalling Vitek 2 AST-N447 Test Kits due to potential for false resistant results caused by pouch foil fractures.
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FDA•MODERATEOmniTract Surgical Retractor SystemIntegra LifeSciences is recalling the OmniTract Surgical Retractor System due to insufficient drying time instructions in the user manual.
FDA•MODERATEGSP Neonatal GALT KitThe GSP Neonatal GALT Kit is recalled due to reduced on-board stability, which may cause test failures and delays in patient results.
FDA•MODERATEFletcher CT/MR Shielded Applicator SetElekta recalls Fletcher CT/MR applicator set due to risk of IU tube tip detachment.
3 products
FDA•MODERATEPemetrexed for Injection 100mg/VialSomerset Therapeutics recalls Pemetrexed for Injection 100mg/Vial due to cGMP deviations.
4 products
FDA•MODERATEKlowen Custom Orthodontic SolutionKlowen is recalling the Custom Orthodontic Solution, model CIAS-800033, due to a defect that may cause incorrect bracket placement.
FDA•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH Enzymatic Hemoglobin A1c assay (Material No. 11097536) due to potential for inaccurate patient results.
FDA•MODERATEMiniMed 780G Insulin PumpMedtronic is recalling MiniMed 780G Insulin Pumps due to a software error that can cause the device to unexpectedly stop delivering insulin.
FDA•MODERATEMedline Anesthesia Kit Peds 90-LFMedline recalls Anesthesia Kit Peds 90-LF due to included temperature probe distribution error.
3 products
FDA•MODERATEGasco Industrial: Multiple Isopropyl Alcohol ProductsGasco recalls Isopropyl Alcohol 70% in multiple sizes due to subpotency, which may reduce antiseptic effectiveness.
6 products
FDA•MODERATE5008X Blood Tubing SetsFresenius recalls 5008X Blood Tubing Sets over potential online port errors.
2 products
FDA•MODERATEIntracept Access InstrumentsBoston Scientific is recalling Intracept Access Instruments due to a potential sterile barrier breach that could lead to severe infection.
FDA•MODERATEEnovis EMPOWR 3D Knee InsertEncore Medical is recalling the EMPOWR 3D Knee Insert (11L 14MM) due to a packaging discrepancy involving incorrect product sizes.
2 products
FDA•MODERATEMasimo Radius VSM NIBP Cuff and ECG SetMasimo recalls Radius VSM NIBP cuffs and ECG sets over false heart-rate alarms and cuff edge irritation.
2 products
FDA•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedVitalant is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated due to missing white blood cell count verification testing.
FDA•MODERATEMethohexital Sodium 100 mg/10 mLQuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL vials due to failed impurities and degradation specifications.
FDA•MODERATEVanilla Dessert ShellsSpecialty Bakers recalls Giant Vanilla Dessert Shells over undeclared soy allergen.
FDA•MODERATEAlabama Banana Pudding MarshmallowWondermade is recalling 4 oz packages of Alabama Banana Pudding Marshmallow due to potential metal contamination.
FDA•MODERATEMedline Remedy Specialized Silicone CreamMedline Remedy Specialized Silicone Cream is recalled due to an out-of-specification result for formaldehyde in the raw material.
FDA•MODERATEClomiphene Citrate USP Active Pharmaceutical IngredientShimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient due to cGMP deviations.
FDA•MODERATESuper Healthy Hair Blow Dry SprayBeauty Pie is recalling Super Healthy Hair Blow Dry Spray (150 ml) due to potential contamination with Pseudomonas aeruginosa.
FDA•MODERATEMethohexital Sodium for Injection 500 mgAvet Pharmaceuticals is recalling Methohexital Sodium for Injection 500 mg vials due to failed impurities and degradation specifications.
FDA•MODERATEAquacel Ag Surgical SP DressingConvaTec is recalling Aquacel Ag Surgical SP dressings because they were manufactured with a thickness exceeding specifications.
FDA•MODERATEWise Onion RingsWise Foods is recalling 3.75 oz bags of Onion Rings due to undeclared colors and the presence of an unapproved color additive.
FDA•MODERATEOlympus Single Use Distal CoverOlympus is replacing the previous design of the MAJ-2315 Single Use Distal Cover used with the EVIS EXERA III Duodenovideoscope.
FDA•MODERATEPedigree High Protein Chopped Ground DinnerMars Petcare is recalling Pedigree High Protein Chopped Ground Dinner over potential contamination with plastic and metal foreign material.
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets due to nitrosamine impurity above ADI.
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 InjectionsAsclemed recalls Accucaine kits and Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL ampules due to lack of sterility assurance.
2 products
FDA•MODERATEA.T.S. 4000 TS Tourniquet Dual HoseZimmer Surgical recalls A.T.S. 4000 TS Tourniquet Dual Hose (Model 60-1812-101-00) due to sterility breach risk.
2 products
FDA•MODERATEGORE TAG Thoracic Branch EndoprosthesisW.L. Gore & Associates is recalling its GORE TAG Thoracic Branch Endoprosthesis due to a device defect.
2 products
FDA•MODERATEBard Acute Drainage TraysBard recalls acute drainage trays due to lidocaine ampoules made under deficient practices.
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 recalls Shiley Disposable Decannulation Plug over incorrect non-DEHP labeling; product contains 30-35% DEHP.
2 products
FDA•MODERATEEunha Fisheries: 2 productsEunha Fisheries recalls Korean halibut and flounder sashimi due to undeclared wheat, soy, sesame, Yellow #5, and Blue #1.
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 Dietary Supplement PHF-CsPH Labs recalls Ocular Plus and Vista MAX supplements due to undeclared Yellow #5.
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.
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- 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.