FDA•MODERATE
da Vinci X and Xi Surgical System Universal Surgical Manipulator
Intuitive Surgical is recalling USM arm sub-assemblies for da Vinci X and Xi systems due to a risk of internal screw breakage.
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FDA•MODERATEOne Step 10A In Vitro Diagnostic TestDFI is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.
7 products
FDA•CRITICALRaw Farm Raw CheddarRaw Farm is recalling Raw Cheddar Original cheese due to a multi-state E. coli O157:H7 outbreak.
5 products
FDA•CRITICALMedline Namic Angiographic Control Syringe KitsWindstone Medical is recalling Angio Pack kits containing Medline Namic syringes due to a risk of adapter disconnection and potential injury.
FDA•CRITICALWawa Iced Tea Lemon 16 ozWawa is recalling 16 oz Iced Tea Lemon bottles due to an undeclared milk allergen.
4 products
FDA•MODERATEEpinephrine Injection USP 1 mg/10mLInternational Medication Systems is recalling Epinephrine Injection 1 mg/10mL (NDC 76329-3318-1) due to lack of sterility assurance.
FDA•MODERATESkin Script Blemish Spot TreatmentSkin Script Blemish Spot Treatment recalled over failed stability specifications; UPC 6 10563 13873 9.
FDA•MODERATEPure Palm Medjool DatesPure Palm is recalling Medjool Dates because they are mislabeled and actually contain Coconut Date Bites.
3 products
FDA•MODERATEPhenylephrine Hydrochloride Injectable SolutionWells Pharma is recalling Phenylephrine Hydrochloride Injectable Solution (40mg, 250mL) due to cGMP deviations.
7 products
FDA•MODERATEi-STAT Blood Gas CartridgesAbbott is recalling i-STAT EG7+, EG6+, and G3+ cartridges due to inaccurate blood gas readings that may lead to incorrect clinical decisions.
3 products
FDA•MODERATEBiofire Spotfire Respiratory/Sore Throat PanelBiofire is recalling the Spotfire Respiratory/Sore Throat Panel due to the risk of false negative results and control failures.
FDA•MODERATEZYMUTEST HIA IgG ELISA KitZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.
FDA•MODERATEErbe Medical ERBEFLO CleverCap CO2 Tubing/Cap SetsErbe Medical is recalling ERBEFLO CleverCap CO2 tubing and cap sets due to a risk of unintended water flow and potential respiratory injury.
3 products
FDA•MODERATEPhilips Azurion Cable Hose CarrierPhilips is recalling Azurion imaging systems due to potential loosening or breakage of Cable Hose Carrier bolts and plastic parts.
FDA•MODERATECoconut Drink 1HEYTEA USA INC is recalling Coconut Drink 1 (1L, UPC 673367992785) due to undeclared milk.
FDA•MODERATEDisposable Mixing Bowls with SpatulaZimmer is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to compromised sterile barrier seals.
FDA•MODERATEBoston Scientific LUX-Dx II Arrhythmia DetectorBoston Scientific is recalling LUX-Dx II arrhythmia detectors due to a software error that prevents proper monitoring and data collection.
2 products
FDA•MODERATEVital Nutrients Aller-C CapsulesBlueroot Health is recalling Aller-C capsules due to undeclared egg, soy, and hazelnut allergens.
FDA•MODERATEPrazosin Hydrochloride Capsules 1mgAppco Pharma is recalling Prazosin Hydrochloride Capsules 1mg due to the presence of N-nitroso-prazosin impurity above acceptable limits.
3 products
FDA•MODERATEMicro-X Rover Mobile X-ray GeneratorMicro-X is recalling the X-ray generator in Rover Mobile X-ray Systems due to a malfunction that can make the device inoperable.
FDA•CRITICALAIDBAG First Aid Kits with McKesson TRUE Metrix PRONorth American Rescue is recalling AIDBAG first aid kits with McKesson TRUE Metrix PRO glucose meters over E-5 error code software defect risking treatment delays.
2 products
FDA•MODERATEStraumann n!ce PMMA Full-arch RestorationStraumann is recalling n!ce PMMA Full-arch Restoration abutments (Article 010.0304) due to an incorrect screw seat interface.
2 products
FDA•MODERATEEdwards EVOQUE Tricuspid Delivery SystemEdwards Lifesciences is updating labeling for the EVOQUE tricuspid delivery system to include a warning about potential functionality issues.
FDA•MODERATEZarlengo's Double Dark Chocolate GelatoZarlengo's Double Dark Chocolate Gelato is recalled due to an undeclared soy allergen.
5 products
FDA•MODERATEEinstein Bros Bagels Honey Almond ShmearEinstein Bros Bagels is recalling Honey Almond Shmear mislabeled as Plain Cream Cheese due to an undeclared almond allergen.
FDA•MODERATEPantoprazole Sodium Delayed-Release Tablets 40 mgCamber Pharmaceuticals is recalling Pantoprazole Sodium 40 mg tablets (NDC 31722-713-10) due to discoloration.
FDA•MODERATEImmy Myco DDR Trident Neutralization Buffer BImmuno-Mycologics is recalling Myco DDR Trident Neutralization Buffer B due to potential contamination.
FDA•MODERATESpacelabs Ultraview SL Command ModuleSpacelabs is recalling the SL Command Module due to a manufacturing issue with the electrical leakage tester.
2 products
FDA•MODERATEGE Revolution CT SystemsGE is recalling Revolution CT systems due to a security vulnerability in the AW Server software used with the CT Smart Subscription feature.
7 products
FDA•MODERATEAlain Milliat Orange MarmaladeAlain Milliat Orange Marmalade is being recalled due to the potential presence of glass fragments in the product.
FDA•MODERATECrab CakesConnecticut Crab Company is recalling crab cakes sold to food service due to potential Clostridium botulinum contamination.
FDA•MODERATEGeri-Care Artificial Tears Lubricant Eye DropsGeri-Care Artificial Tears Lubricant Eye Drops (0.5 oz, NDC 68788-7266-0) recalled due to lack of sterility assurance.
FDA•MODERATEBombay Kitchen Tikka SevBombay Kitchen Tikka Sev is recalled due to undeclared FD&C Yellow #6 and FD&C Red #40 food dyes.
3 products
FDA•MODERATEFluocinonide 0.05% CreamTaro Pharmaceuticals is recalling Fluocinonide 0.05% Cream due to out-of-specification viscosity results.
3 products
FDA•MODERATEOxoid Salmonella 9-O Agglutinating SeraRemel Europe is recalling Oxoid Salmonella 9-O Agglutinating Sera due to potential cross-reactivity and misidentification risks.
FDA•MODERATEAvitene Ultrafoam Microfibrillar Collagen HemostatDavol is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog 1050030) due to potential inspect fragment contamination.
FDA•MODERATEOlympus OER-ELITE Endoscope Reprocessor Connecting TubesOlympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (model MAJ-2110) due to potential premature failure of the lock levers.
12 products
FDA•CRITICALVOCSN V+Pro Respiratory SystemVentec is recalling VOCSN V+Pro respiratory systems (REF: PRT-01198-000, PRT-01185-000) due to potential oxygen leaks that may increase fire risk.
FDA•MODERATEDEX Ophthalmic Tissue ForcepsKatalyst Surgical is updating the Instructions for Use for DEX Ophthalmic Tissue Forceps and 23ga DEX NanoTapered AWH Forceps.
12 products
FDA•MODERATEBioCera Fibers Bone Void FillerOrthorebirth is recalling BioCera Fibers bone void filler products that do not meet standard manufacturing specifications.
2 products
FDA•CRITICALOmnicell i.v.STATION Syringe Label StockOmnicell is recalling i.v.STATION syringe label stock due to the potential for mislabeled IV medication syringes.
FDA•MODERATEOmnipaque (iohexol) InjectionGE Healthcare is recalling Omnipaque (iohexol) injection due to the presence of particulate matter.
2 products
FDA•MODERATEMemantine Hydrochloride Extended-Release 7 mg CapsulesMajor Pharmaceuticals is recalling Memantine Hydrochloride Extended-Release 7 mg capsules (NDC 0904-6734-61) due to failed dissolution specifications.
FDA•CRITICALSalute Seasonings Ground All SpiceSalute Seasonings Ground All Spice (16 oz) recalled for possible Salmonella contamination.
FDA•CRITICALAyco Fresh CantaloupeAyco Farms is recalling whole fresh cantaloupes due to potential Salmonella contamination.
FDA•MODERATEHamilton AutoLys STAR Protocol Configuration Tool SoftwareFoundation Medicine recalls PCT software v1.3.0 for Hamilton AutoLys STAR due to risk of spontaneous software closures during protocol execution.
FDA•MODERATERemel Yeastone BrothRemel is recalling Yeastone Broth due to the potential for inaccurate antimicrobial susceptibility testing results.
FDA•CRITICALMedline Namic Angiographic ManifoldMedline is recalling custom Namic Angiographic Manifolds due to the presence of particulate matter within the fluid path.
14 products
FDA•MODERATEICU Medical Oncology Extension SetICU Medical is recalling Oncology Extension Set REF: CL3960 due to a potential leak that could cause therapy interruption or hazardous exposure.
FDA•MODERATEBooey's Dragon's Breath SauceBooey's Dragon's Breath sauce is recalled for undeclared fish (anchovy) and sesame allergens.