FSIS•MODERATE
Meat and Poultry Products with Recalled Dairy Ingredients
FSIS alert: meat & poultry products with recalled dairy ingredients may be contaminated with Salmonella.
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FDA•MODERATEMy Mochi Strawberry Non-Dairy Frozen DessertMy Mochi Strawberry Non-Dairy Frozen Dessert recalled due to foreign object in container.
FDA•MODERATECalypso Tropic Tango LemonadeCalypso Tropic Tango Lemonade recalled for undeclared Yellow No. 5.
FDA•LOWCVS Lidocaine Wound GelCVS is recalling Lidocaine Wound Gel (NDC 59898-950, 0.5 oz) due to failed pH specifications.
FDA•MODERATEMedline Universal Central/Art Line Insertion KitMedline recalls kits with Webcol Alcohol Prep Pads due to possible non-sterility and contamination risk.
10 products
FDA•MODERATEAlendronate Sodium Oral Solution 70 mg/75 mLHikma is recalling Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59) due to out-of-specification assay results.
FDA•MODERATEImmy Myco DDR Trident Neutralization Buffer BImmuno-Mycologics is recalling Myco DDR Trident Neutralization Buffer B due to potential contamination.
FDA•MODERATEATTUNE Revision Hinge FemoralDepuy Synthes recalls ATTUNE Revision Hinge Femoral over packaging adhesion that may compromise sterility.
9 products
FDA•MODERATEepoc BGEM BUN Test CardSiemens is recalling epoc BGEM BUN Test Cards due to inaccurate pH and mTCO2 results that could lead to improper patient treatment.
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•LOWPALAMIX uno Mixing UnitHeraeus recalls PALAMIX uno mixing units: mixing rod may loosen in units over 17 months old; shelf life reduced to 1.5 years.
2 products
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•CRITICALLactated Ringer's Injection USPB. Braun Medical is recalling Lactated Ringer's Injection USP due to the presence of particulate matter.
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•LOWLevocarnitine Injection, USPAmerican Regent is recalling Levocarnitine Injection, USP, 1 g/5 mL single-dose vials due to missing labels.
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•MODERATEAlcon Research: Multiple Lubricant Eye GelsAlcon recalls Systane and GenTeal eye gels over sterility concerns.
2 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•LOWMonsel's Ferric Subsulfate Solution 8 mLPremier Dental Products is recalling Monsel's Ferric Subsulfate Solution 8 mL vials (NDC 48783-112-08) due to incorrect expiration date on the vial label.
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•CRITICALFrench Broad Chocolate Bette's Bake Sale BonbonsFrench Broad Chocolate recalls Bette's Bake Sale bonbons over undeclared walnut allergen.
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•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•LOWMagnesium Chloride 6-Hydrate Crystal 500GAvantor is recalling Magnesium Chloride 6-Hydrate Crystal 500G bottles (NDC 10106-2448-1) due to subpotency.
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
FDA•MODERATEOlympus OER-ELITE Connecting TubesOlympus recalls OER-ELITE connecting tubes (MAJ-2110) due to premature lock lever failure.
12 products
FDA•MODERATEnanOss 3D Advanced Bone Graft SubstituteXTANT Medical is recalling nanOss 3D bone graft substitutes due to an incorrect five-year shelf life label.
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•MODERATEAvitene Ultrafoam Microfibrillar Collagen HemostatDavol is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog 1050030) due to potential inspect fragment contamination.
FDA•MODERATEGentuity HF-OCT Imaging SystemGentuity is correcting HF-OCT Imaging System software (versions 21.11–23.3.13) to prevent inaccurate longitudinal measurements during imaging.