FDA•MODERATE
Wells Pharma of Houston: multiple injections
Wells Pharma recalls injectable drugs (phenylephrine, fentanyl, ketamine) over cGMP deviations.
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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•CRITICALGhirardelli Chocolate: 11 Company CasGhirardelli recalls frappe mixes and hot cocoa over possible Salmonella contamination.
11 products
FDA•MODERATEPhilips Achieva 1.5T MREPhilips recalls Achieva 1.5T MRE over stiffness value errors from incorrect voxel size settings.
19 products
FDA•CRITICALEnoki MushroomsEnoki Mushrooms are being recalled due to potential Listeria monocytogenes contamination.
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•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•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•CRITICALBoston Scientific PacemakersBoston Scientific updates software for certain pacemakers and CRT-Ps due to bradycardia maintenance release.
3 products
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.
FDA•CRITICALFrench Broad Chocolate Bette's Bake Sale BonbonsFrench Broad Chocolate recalls Bette's Bake Sale bonbons over undeclared walnut allergen.
FDA•CRITICALHeritage Animal Nutrition Medicated FeedHeritage Animal Nutrition is recalling 50 lb bags of medicated feed due to potential rumensin contamination.
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•CRITICALKirkland Signature Traditional MadeleinesCostco recalls Kirkland Signature Traditional Madeleines over undeclared hazelnut and soy lecithin.
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•MODERATEBombay Kitchen Brand: 3 productsEthnic Foods Inc is recalling Bombay Kitchen brand Punjabi Mix and Tikka Sev snack products due to undeclared FD&C Yellow #6 and FD&C Red #40 artificial colors, which are not listed in the ingredients.
3 products
FDA•LOWAmprol 25% Medicated ArticleHuvepharma is recalling one bag of Amprol 25% medicated article due to missing lot number and expiration date information.
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.
FDA•CRITICALRevival Animal Health: 2 Packaged In The Following SizesRevival Animal Health recalls Breeder's Edge and Shelter's Choice puppy milk replacers due to incorrect vitamin D levels.
2 products
FDA•MODERATESilver Moon: 48 products48 Silver Moon products recalled over tree nuts, peanuts, milk, eggs, soy, wheat, sulfites, and other hazards.
48 products
FDA•MODERATEUvlizer Handheld UV-C Germicidal WandUvlizer UV-C germicidal wands can expose users to unsafe UV-C radiation levels above international safety guidelines.
- FDA•MODERATEUvlizer Handheld UV-C Germicidal Wand
Uvlizer UV-C germicidal wands may expose users to unsafe UVC radiation levels above international safety guidelines.
FDA•MODERATEClaravis (isotretinoin capsule, USP) 10 mgTeva is recalling Claravis 10 mg capsules (NDC 0555-1054-56, 0555-1054-86) due to out-of-specification Tretinoin impurity levels.
3 products
FDA•MODERATEMemantine Hydrochloride Extended-Release CapsulesMajor Pharmaceuticals is recalling 7 mg Memantine Hydrochloride Extended-Release Capsules due to failed dissolution specifications.