FDA•MODERATE
Philips Azurion Image Guided Therapy System
Philips is recalling Azurion 3 and 7 M12 systems over a software defect that can cause unexpected patient table movement.
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FDA•MODERATETops GOLD PicklesMangalm is recalling Tops GOLD pickle products due to potential erucic acid contamination from mustard oil.
6 products
FDA•MODERATEI.T.S. Headless Compression Screw SystemI.T.S. is recalling the Headless Compression Screw System due to higher-than-expected temperature increases during MRI procedures.
24 products
FDA•MODERATEDatascope CS300 IABPDatascope is updating the IFU for CS300 IABP software version C.01 to correct battery runtime and cycle specifications.
2 products
FDA•MODERATERed Button Movie House PopcornRed Button Movie House Popcorn is being recalled due to the potential presence of foreign material.
FDA•MODERATEBisoprolol Fumarate and Hydrochlorothiazide Tablets 2.5 mg/6.25 mgUnichem Pharmaceuticals recalls Bisoprolol/Hydrochlorothiazide 2.5/6.25 mg tablets (NDC 29300-187-01) due to N-Nitroso Bisoprolol impurity specification failure.
FDA•MODERATEAuris Health MONARCH Platform Bronchoscopy SystemAuris Health is recalling MONARCH Platform Bronchoscopy systems due to a software issue that may cause unexpected robotic arm repositioning and contact with the patient.
FDA•MODERATEEVO+ Visian Toric Implantable Collamer Lens (TICL)Staar Surgical is recalling EVO+ Visian Toric ICL Model VTICM5 due to incorrect length labeling (12.1 mm labeled vs. 12.6 mm actual) causing excessive vault and potential angle closure.
FDA•MODERATEPhysio-Control Infant/Child Defibrillator ElectrodesPhysio-Control is recalling infant/child defibrillator electrodes due to a risk of delamination that may prevent proper therapy delivery.
2 products
FDA•MODERATEMOLLI 2 Surgical Marker SystemStryker is updating the MOLLI 2 System labeling due to the risk of magnetized surgical tools dislodging markers during tissue removal.
2 products
FDA•MODERATEAdapt Pump Model 61600200Agiliti is recalling Adapt Pump Model 61600200 due to Microclimate Management function failure after Autofirm use.
FDA•MODERATECrunchy Caramel Dark ChocolateGarcia Nevett is recalling Crunchy Caramel dark chocolate bars due to an undeclared milk allergen.
FDA•MODERATEMed Nap BZK Antiseptic TowelettesAcme United is recalling Med Nap BZK Antiseptic Towelettes (NDC 0924-0246-01) due to CGMP deviations.
22 products
FDA•MODERATEGEM Premier 5000 PAKInstrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to errors that may cause cartridge ejection and delayed results.
20 products
FDA•MODERATECobas Pro Integrated Solutions Analytical UnitsRoche is recalling cobas pro analytical units due to a software defect causing erroneous, repeated lab results for specific Spline-type assays.
2 products
FDA•MODERATEAtellica CH Urine Albumin TestSiemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.
FDA•MODERATERoasted Tomato and Parmesan Focaccia BreadBakkavor is recalling various roasted tomato and parmesan focaccia breads due to potential metal fragment contamination.
3 products
FDA•MODERATEVegetarian Chicken Flavor RamenPalmetto Gourmet Foods is recalling Vegetarian Chicken Flavor Ramen due to undeclared Yellow #5.
2 products
FDA•MODERATEPremium Food Jordan AlmondsPremium Food Jordan Almonds are recalled for undeclared wheat and artificial colors.
2 products
FDA•MODERATESimply Nature Spinach BitesDr. Praeger's is recalling Simply Nature Spinach Bites (12 oz) due to possible rodent hair contamination.
FDA•MODERATEWoodland Gourmet Arrowroot FlourWoodland Gourmet Arrowroot Flour is being recalled due to the potential presence of foreign material.
FDA•MODERATEThyroid, USPSpecialty Process Labs is recalling Thyroid, USP (NDC 81305-100-02) due to subpotency.
FDA•MODERATEMediHoney Gel DressingIntegra LifeSciences is recalling MediHoney Gel dressing (catalog numbers 31805 and 31815) due to a potential sterile barrier breach.
3 products
FDA•MODERATEGE Healthcare Centricity Universal Viewer Zero Footprint ClientGE Healthcare is recalling Centricity Universal Viewer Zero Footprint Client (Models 2110344-039, -046, -047) due to patient information and image mismatch risk.
FDA•MODERATEAonic Complete Hers Dietary SupplementAonic Complete Hers dietary supplement shots are recalled due to potential E. coli, coliforms, and Pseudomonas aeruginosa contamination.
2 products
FDA•MODERATEWinCo Foods Deli Margherita PizzaWinCo Foods is recalling Deli Margherita Pizza Thin Crust due to potential metal fragment contamination.
FDA•MODERATEMethylprednisolone Tablets USP Dosepak 4 mgGreenstone is recalling methylprednisolone 4 mg tablets (NDC 59762-4440-2) due to incorrect blister foil orientation causing incorrect dosing information.
FDA•MODERATEReverse Shoulder Prosthesis Humeral Socket InsertEncore Medical is recalling the Reverse Shoulder Prosthesis Humeral Socket Insert (model 509-00-432) due to incorrect labeling.
3 products
FDA•MODERATEAesculap Minop TrocarAesculap is recalling the Minop Trocar 150mm (Model FF399R) due to a potential defect where the trocar shaft length may be too long.
FDA•MODERATEMedline Unna-Z Stretch Zinc Paste BandageMedline is recalling Unna-Z Stretch Zinc Paste Bandages due to a labeling error that omits castor oil and calamine from the ingredient list.
FDA•MODERATEMargarita Thin Crust PizzaRose and Shore is recalling Margarita Thin Crust Pizzas due to potential metal contamination in the tomato ingredient.
FDA•MODERATESpicely Organic Garlic SaltSpicely Organic Garlic Salt is recalled due to undeclared salt in the product.
3 products
FDA•MODERATESevillo Fine Foods Slow Roasted Diced TomatoesSevillo Fine Foods is recalling 24 lb bulk boxes of frozen Slow Roasted Diced Tomatoes due to potential metal fragment contamination.
2 products
FDA•MODERATEOxycodone Hydrochloride Tablets, USP 5 mgAmerican Health Packaging is recalling Oxycodone Hydrochloride 5 mg tablets due to defective blister card seals that allow tablets to fall out.
FDA•MODERATEPIE PAK Trolley SystemEdermy is recalling PIE PAK trolley system models P2HC-A, P2HC-S, and P2HC due to a lack of required 510(k) clearance.
2 products
FDA•MODERATESpicy Breakfast BurritoMG Foods is recalling 10 oz Spicy Breakfast Burritos due to potential contamination with small hard plastic fragments.
FDA•MODERATEOctopus Nuvo Tissue StabilizerMedtronic is recalling Octopus Nuvo Tissue Stabilizer (TSMICS1) due to incorrect tubing assembly that may affect surgical tissue stabilization.
FDA•MODERATELaerdal Compact Suction Unit 4 RTCALaerdal is recalling Compact Suction Unit 4 RTCA models due to potential electromagnetic noise interference exceeding safety standards.
FDA•MODERATESpectrum IQ Infusion PumpBaxter is recalling Spectrum IQ Infusion Pumps (Model 3570009) because they were released without full occlusion alarm testing.
FDA•MODERATESonic TotsMcCain Foods is recalling Sonic Tots due to potential contamination with small hard plastic fragments.
2 products
FDA•MODERATEIsotretinoin 40 mg CapsulesTeva is recalling Isotretinoin 40 mg capsules due to superpotency and subpotency concerns that may affect treatment efficacy or safety.
2 products
FDA•MODERATEEndo-Model Knee Replacement PlateauWaldemar Link is recalling the Endo-Model Replacement Plateau due to a risk of longitudinal fracture that may cause bushing detachment.
13 products
FDA•MODERATEFurosemide Tablets USP 40 mgRising Pharmaceuticals is recalling Furosemide Tablets 40 mg (NDC 64980-563-10) due to foreign substance contamination.
FDA•MODERATESea Moss Gel SuperfoodDiva Fam is recalling Sea Moss Gel Superfood due to potential Clostridium botulinum contamination.
14 products
FDA•MODERATEAPTUS 2.5 TriLock Screw 16mmMedartis is recalling APTUS 2.5 TriLock Screw 16mm (Model A-5750.16/1) due to a packaging mix-up with 2.8mm screws.
2 products
FDA•MODERATEMaquet Venous Bubble SensorMaquet is recalling Venous Bubble Sensors for 3/8" x 3/32" tubing due to cable durability issues that may cause sensor failure.
FDA•MODERATEFDR Visionary Suite X-ray GeneratorFDR Visionary Suite X-ray generators are being recalled due to a risk of overheating and smoke caused by faulty electromagnetic contactors.
FDA•MODERATEDiowave 250W Laser SystemDiowave 250W Laser System recalled; software update needed to correct power output exceeding FDA-cleared 60W limit.
FDA•MODERATESmoked Grouper DipIsland Crab Corporation is recalling Smoked Grouper Dip due to undeclared milk, eggs, and sodium metabisulfite.
FDA•MODERATEMedline Dialysis Insertion KitsMedline is recalling dialysis insertion kits due to defective Tego Connector silicone seals that may cause leakage or therapy interruption.
6 products