FDA•CRITICAL
UDENYCA Pegfilgrastim-cbqv Injection
UDENYCA pegfilgrastim-cbqv prefilled syringes (Lot 2199821) recalled due to improper storage temperature.
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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•CRITICALOlympus High Flow Insufflation UnitOlympus is recalling the High Flow Insufflation Unit, Model UHI-3, due to a software issue that may cause overpressure events.
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•CRITICALLive it Up Super Greens Dietary SupplementLive it Up Super Greens dietary supplement is recalled due to potential Salmonella Typhimurium contamination.
4 products
FDA•LOWLubna Quality Products Mung BeansLubna Quality Products is recalling 4 lb mung bean packages due to unapproved pesticide (Thiamethoxam) contamination.
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•LOWSodexo Stars Saccharin Pink PacketsSodexo Stars Saccharin (Pink) packets are recalled due to undeclared aspartame, which may pose a risk to individuals with PKU.
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•CRITICALADM Animal Nutrition MasterPlex 75P 30/30 RU 55010CDHADM Animal Nutrition recalls MasterPlex 75P 30/30 RU 55010CDH medicated cattle feed due to incorrect labeling causing monensin/urea toxicity.
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•CRITICALOutside The Breadbox Bread CrumbsOutside The Breadbox is recalling 8 oz Bread Crumbs due to undeclared egg and milk allergens.
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
FDA•MODERATEOlympus ShockPulse-SE Lithotripsy System GeneratorOlympus is recalling ShockPulse-SE Lithotripsy System generators due to a mis-wired component that may cause treatment delays.
2 products
FDA•MODERATEGluten Free Seasoned Vegan Pizza CrustRich Products Corp is recalling Gluten Free 14" Seasoned Vegan Pizza Crust due to undeclared milk and egg allergens.
2 products
FDA•MODERATEHannaford Hamburger Dill Pickle ChipsHannaford hamburger dill pickle chips (UPC 0 41268 14889 9) recalled due to glass contamination.
FDA•MODERATEOlympus Single Use 3-Lumen Sphincterotome VOlympus is recalling the Single Use 3-Lumen Sphincterotome V (Model KD-V411M-1520) due to a manufacturing defect that may cause device deformation.
30 products
FDA•MODERATEMedline Surgical Convenience KitsMedline is recalling various surgical convenience kits due to potential issues with sterilization and packaging calibration.
62 products
FDA•MODERATEPhilips Brilliance iCT and Spectral CT 7500 Gantry RotorPhilips is recalling Brilliance iCT and Spectral CT 7500 systems because improperly torqued gantry fasteners may cause rotor parts to detach.
4 products- Device RecallFDA•MODERATEMint Lesion Software
Mint Medical is recalling Mint Lesion software versions 3.4.0–3.9.5 due to a risk of data loss or incorrect patient record linking.
FDA•MODERATEMedline Convenience KitsMedline is recalling convenience kits due to potential sterility issues caused by equipment calibration errors.
58 products
FDA•MODERATEKarison PanjiriKarison is recalling Panjiri in 12 oz containers due to undeclared milk, a known allergen.
5 products
FDA•CRITICALCarrot Top Kitchens Lime Ginger HummusCarrot Top Kitchens is recalling 8 oz Lime Ginger Hummus due to undeclared sesame.
5 products
FDA•MODERATEPrismaflex M100 SetVantive is recalling the Prismaflex M100 Set due to a potential deaeration chamber dislodgement risk.
8 products
FDA•LOWStraumann WB Impression Post Closed TrayStraumann is recalling WB Impression Post Closed Tray kits (L 13mm) due to incorrect magenta impression caps instead of brown.
FDA•CRITICALHerbsForever Gastro Care Herbal SupplementHerbsForever is recalling Gastro Care herbal supplement capsules due to undeclared wheat.
2 products
FDA•MODERATEAQ 120 GFEW Aquarion Preserved CartridgesEncon Safety Products is recalling AQ 120 GFEW Aquarion Preserved Cartridges due to cGMP manufacturing deviations.