FDA•MODERATE
Straumann n!ce PMMA Full-arch Restoration
Straumann is recalling n!ce PMMA Full-arch Restoration abutments (Article 010.0304) due to an incorrect screw seat interface.
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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.
FSIS•MODERATEBlackwing Organic Meats Beef and Pork ProductsBlackwing Organic Meats beef and pork products (April 2024–March 2026) produced without federal inspection may contain undeclared allergens or harmful bacteria.
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•LOWFarmina Pet Foods N&D Tropical Selection Dog FoodFarmina Pet Foods N&D Tropical Selection dog food (22 lb, UPC 8 01027 60423 85) recalled due to mislabeling—front lists salmon, back lists lamb.
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•LOWHeraeus PALAMIX uno Mixing SystemHeraeus is reducing the shelf life of PALAMIX uno mixing systems to 17 months due to a risk of the mixing rod detaching during use.
2 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•LOWGarland Fresh Peeled GarlicGarland Fresh Peeled Garlic 6 oz. bags are recalled due to potential Clostridium botulinum contamination from temperature abuse.
2 products
FDA•LOWSunRidge Farms Organic Black BeansSunRidge Farms Organic Black Beans are being recalled due to potential contamination with haloxyfop and thiamethoxam pesticides.
3 products
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.
FSIS•MODERATEWhite Oak Pastures Grassfed Ground BeefWhite Oak Pastures Grassfed Ground Beef (16 oz) may contain metal; do not consume.
FDA•MODERATEBooey's Dragon's Breath SauceBooey's Dragon's Breath sauce is recalled for undeclared fish (anchovy) and sesame allergens.
FDA•MODERATEGentuity HF-OCT Imaging SystemGentuity is correcting the HF-OCT Imaging System (Model G10-01) to address a software issue that may cause inaccurate length measurements.
FDA•MODERATEOlympus Thunderbeat II ShearsOlympus is recalling Thunderbeat II Shears (Model TB2-0520FC) due to the risk of a distal tip component detaching during use.
4 products- Device RecallFDA•MODERATEGenius Digital Diagnostics System Review Station Display
Hologic is correcting Genius Review Station displays due to unauthorized configuration changes that deviate from validated settings.
FDA•MODERATEHiResolution Bionic Ear System M Zn-Air Battery PakAdvanced Bionics is recalling M Zn-Air Battery Paks for cochlear implants due to a non-compliant battery door design.
2 products
FDA•MODERATETangent Single Use Digital CatheterTangent Endoscopy is recalling single-use digital catheters due to a risk of fractures at the distal shaft tip.
FDA•MODERATEVancomycin HCl InjectionFagron is recalling Vancomycin HCl 1.5g/250mL injection due to sterility concerns and a potential detachment of the administration port part.
5 products
FDA•MODERATEExchange Select Honey Lemon Cough DropsExchange Select Honey Lemon Cough Drops are recalled due to manufacturing facility inspection observations that may impact product quality.
15 products
FDA•MODERATEFurosemide Tablets, USP 80 mgLeading Pharma is recalling Furosemide Tablets 80 mg (NDC 69315-118-01) due to N-nitroso-Furosemide above recommended limits.
FDA•MODERATEFoundationOne CDx Sequencing Agent SEQ0067Foundation Medicine is recalling Sequencing Agent SEQ0067 component of FoundationOne CDx due to possible false-positive BARD1 variants.
FDA•LOWBee Well Wildflower HoneyBee Well Honey Farm & Supply is recalling Wildflower Honey in 12 oz, 22 oz, and 44 oz sizes due to high C4 sugar content.
FDA•MODERATEProdisc C SK U.S. Cervical Disc ImplantCentinel Spine is recalling Prodisc C SK U.S. cervical disc implants due to a labeling mix-up between 5mm and 6mm sizes.
2 products
FDA•MODERATERiverence Smoked Trout DipRiverence is recalling Smoked Trout Dip due to an undeclared milk allergen.
FDA•MODERATETramadol Hydrochloride Tablets, USP 50 mgAmneal is recalling tramadol 50 mg tablets (NDC 60219-2348-5) due to elevated N-nitroso-desmethyl-tramadol impurity.
FDA•MODERATEClonidine Transdermal System 0.2 mg/dayTeva Pharmaceuticals is recalling Clonidine Transdermal System 0.2 mg/day due to the use of an unapproved raw material during manufacturing.
3 products
FDA•CRITICALBoston Scientific Essentio, Proponent, Accolade, and Altrua 2 PacemakersBoston Scientific is updating software for Essentio, Proponent, Accolade, and Altrua 2 pacemakers to address dual-chamber device performance.
3 products