FDA•MODERATE
Straumann n!ce PMMA Full-arch Restoration
Straumann recalls n!ce PMMA Full-arch Restoration due to incorrect screw seat interface.
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FDA•MODERATEBD GasPak EZ CO2 Pouch SystemBD recalls GasPak EZ CO2 and Campy pouch systems over low CO2 output.
2 products
FDA•MODERATEPhilips Bridge Prep KitMerit Medical recalls Philips Bridge Prep Kit (REF K12-09098B) over catheter resistance on guidewire.
4 products
FDA•MODERATEi-STAT EG7+ CartridgeAbbott recalls i-STAT EG7+ cartridges (03P76-25) over inaccurate PCO2/pH results.
3 products
FDA•MODERATELeksell Vantage Arc SystemElekta is recalling the Leksell Vantage Arc System due to a risk of coordinate shifting caused by faulty locking mechanisms.
FDA•MODERATEiLet Bionic PancreasBeta Bionics is recalling iLet Bionic Pancreas (software 1.4.2–1.4.3) for Dexcom G7 compatibility issues that may disable glucose correction dosing.
FDA•MODERATEOptase Dry Eye Intense DropsScope Health is recalling Optase Dry Eye Intense Drops (0.33 fl oz, NDC 72972-002-01) due to lack of assurance of sterility.
FDA•MODERATEThea Pharma: Multiple Sterile Lubricant Eye DropsThea Pharma recalls iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) over sterility concerns from CGMP deviations.
2 products
FDA•MODERATENegita Cracker ShrimpHadson is recalling Negita Cracker Shrimp 2.8 oz over undeclared FD&C Yellow 6.
FDA•MODERATESpecially Selected Vanilla Creme BruleeLactalis recalls Specially Selected Vanilla Creme Brulee over possible glass fragments.
FDA•MODERATEWells Pharma of Houston: multiple injectionsWells Pharma recalls injectable drugs (phenylephrine, fentanyl, ketamine) over cGMP deviations.
7 products
FDA•MODERATEDimension Creatinine Flex Reagent CartridgeSiemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.
FDA•MODERATEPhilips Achieva 1.5T MREPhilips recalls Achieva 1.5T MRE over stiffness value errors from incorrect voxel size settings.
19 products
FDA•MODERATEHiResolution Bionic Ear M Zn-Air Battery PakAdvanced Bionics is recalling M Zn-Air Battery Paks for sound processors due to a non-compliant battery door design.
2 products
FDA•MODERATEUncle Giuseppe's Marketplace Milk Chocolate Bridge MixUncle Giuseppe's Marketplace Milk Chocolate Bridge Mix is recalled for undeclared cashews, milk, and soy allergens.
FDA•MODERATEAlcon Research: Multiple Lubricant Eye GelsAlcon recalls Systane and GenTeal eye gels over sterility concerns.
2 products
FDA•MODERATEGuangdong Zonegoing Food: 6 Brand Popping Bobas52USA Popping Boba (Strawberry, Mango, Passion Fruit) recalled for unapproved colors.
6 products
FDA•MODERATEOmega-3-Acid Ethyl Esters CapsulesMajor Pharmaceuticals is recalling Omega-3-Acid Ethyl Esters Capsules due to failed stability testing for capsule shell loss on drying.
FDA•MODERATEMedtronic Sphere-9 Cardiac Ablation CatheterMedtronic Sphere-9 Catheter (Model AFR-00001) may cause ventricular fibrillation in patients with Biotronik ICDs or CRT-Ds during radiofrequency ablation therapy.
FDA•MODERATEDisposable Mixing Bowls with SpatulaZimmer is recalling Disposable Mixing Bowls with Spatula due to compromised sterile barrier seals that may lead to infection.
FDA•MODERATEMilestone Vacuum Bag SU Large Specimen ContainerMilestone is recalling Vacuum Bag SU Large specimen containers (Model 68409SS) due to possible reagent leakage.
FDA•MODERATEHealthmark Mesh Style Tip ProtectorsHealthmark is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) because they lack required FDA clearance.
FDA•MODERATEKiwi Omni Vacuum Delivery SystemClinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to a risk of device breakage during use.
FDA•MODERATEGenius Digital Diagnostics System Review Station DisplayHologic is recalling Genius Review Station displays (Model CMP-01669) due to unauthorized user modifications to validated monitor settings.
FDA•MODERATEFrederik's Vanilla Bourbon Trail MixFrederik's Vanilla Bourbon Trail Mix recalled for undeclared wheat and soy allergens.
CPSC•AMZCMJ DGD Children's Tower StoolsAMZCMJ DGD children's tower stools are recalled due to collapse, tip-over, and entrapment hazards that pose a risk of serious injury or death.
CPSC•TOETOL HOME Children's Tower StoolsTOETOL HOME is recalling children's tower stools (model DETD0001) due to serious injury and death risks from entrapment, falls, and tip-overs.
CPSC•Cpzzkq Baby LoungersCpzzkq baby loungers are recalled due to a suffocation hazard that violates federal safety standards for infant support cushions.
CPSC•KMUYSL Big Red Barn Farm Animal PlaysetsKMUYSL Big Red Barn Farm Animal Playsets (model SY-MZ7S-TVMV) are recalled due to a choking hazard from detachable small parts.
CPSC•Magnetic Stick Figure SetsMagnetic stick figure sets are recalled due to a serious magnet ingestion hazard that can cause severe injury or death in children.
CPSC•mGanna Sodium Hydroxide Pellet BagsmGanna sodium hydroxide pellet bags are recalled for lacking child-resistant packaging, posing a chemical burn and irritation risk.
CPSC•Autobrush Sonic Pro Children's Toothbrush BoxesAutobrush is recalling Sonic Pro children's toothbrush boxes due to a battery ingestion hazard from the packaging's coin cell battery.
CPSC•32 Degrees Heated Socks32 Degrees is recalling heated socks due to a burn hazard that can occur during high-intensity activities.
CPSC•FitRx SmartBell Quick-Select Adjustable DumbbellsTzumi Electronics is recalling FitRx SmartBell adjustable dumbbells due to an impact injury hazard from dislodging weight plates.
CPSC•Sweetie Baby and Style Life Eleven Baby LoungersSweetie Baby and Style Life Eleven baby loungers are recalled due to suffocation and fall hazards that violate federal safety standards.
CPSC•Wiifo Children's Tower StoolsWiifo is recalling children's tower stools (Model LT005) due to collapse, tip-over, and entrapment hazards.
FDA•MODERATEMarquez Brothers International: 3 productsMarquez Brothers recalls horchata mixes over undeclared milk allergen.
3 products
FDA•MODERATEB. Braun Sterile Water for Injection 3000 mLB. Braun recalls Sterile Water for Injection 3000 mL bags over sterility and leakage risk.
4 products
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•MODERATEDiversatek Viper Balloon DilatorDiversatek recalls Viper 3-Stage Balloon Dilator (6-7-8mm) due to incorrect inflation tag info.
4 products
FDA•MODERATEFreshKote Lubricant EyedropsHarrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.
FDA•MODERATESkin Script Blemish Spot TreatmentSkin Script Blemish Spot Treatment recalled over failed stability specifications; UPC 6 10563 13873 9.
FDA•MODERATEWindstone Custom Convenience Kits Pre Op KitWindstone recalls Custom Convenience Kits Pre Op Kit (Part AMS14433) due to potential IV backflow and priming issues.
3 products
FDA•MODERATEMicro-X Rover Mobile X-ray SystemMicro-X is recalling the Rover Mobile X-ray System due to a generator malfunction that can render the device inoperable.
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•MODERATEFoundationOne CDx Sequencing Agent SEQ0067Foundation Medicine is recalling Sequencing Agent SEQ0067 component of FoundationOne CDx due to possible false-positive BARD1 variants.
FDA•MODERATELSL Infant Central Line Dressing Change KitLSL Healthcare recalls Infant Central Line Dressing Change Kit (Model 2925H) due to non-sterile alcohol prep pads.
6 products
FDA•MODERATEArrow Echogenic Introducer NeedleArrow recalls Echogenic Introducer Needle due to incorrectly manufactured liquid adhesive.
13 products
FDA•MODERATEAccess Total T4 CalibratorBeckman Coulter is recalling Access Total T4 Calibrator (Catalog No. 33805) due to negative bias causing falsely low results on DxI 600/800 instruments.
FDA•MODERATEFlamingo Funnel SmallSurgiSmoke recalls Flamingo Funnel Small over sterilization drape nonconformance.
3 products