FDA•MODERATE
Healthmark Mesh Style Tip Protectors
Healthmark is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) because they lack required FDA clearance.
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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.
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•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•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.
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.
FDA•MODERATEPantoprazole Sodium Delayed-Release Tablets 40 mgCamber Pharmaceuticals is recalling Pantoprazole Sodium 40 mg tablets (NDC 31722-713-10) due to discoloration.
FDA•MODERATEMedline Namic GuidewiresMedline recalls Namic syringes, guidewires, and tubing due to rescinded 510(k) clearances.
28 products
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline is recalling convenience kits containing select 10mL polycarbonate syringes due to potential cracking or breakage of the syringe barrel and/or plunger, which could result in loss of sterility and potential patient infection.
21 products
FDA•MODERATELeadCare II Blood Lead Test KitsMagellan recalls LeadCare II blood lead test kits over false elevated results from certain micro-collection devices.
4 products
FDA•MODERATECUSA Clarity C7000 ConsoleIntegra LifeSciences is recalling CUSA Clarity C7000 Console (Software 2.1.1.909) due to unresponsive touch screen.
FDA•MODERATESoft-Vu Angiographic CatheterAngiodynamics recalls Soft-Vu Angiographic Catheters due to guidewire passage defect.
20 products
FDA•CRITICALMedline Namic Angiographic Control SyringesWindstone recalls kits with Medline Namic RA Syringes over risk of adapter unwinding, which may cause disconnection and serious injury.
CPSC•Fisher & Paykel Gas RangesThe affected units were sold nationwide and include various RGV3 series models with serial numbers starting with EEV, ERV, EAV, EYV, EUV, ELV, or RFV.
CPSC•ATOYUS Children's Activity CubesATOYUS children's activity cubes (Model GLBB554) are recalled due to a choking hazard from small parts that can detach.
CPSC•Zoliquex Adult Portable Bed RailsZoliquex is recalling model ZEX014-V1 adult portable bed rails due to serious entrapment and asphyxiation hazards.
CPSC•Fengrong Tool Electric Pressure WashersFengrong Tool is recalling electric pressure washers due to a serious risk of injury or death from shock and electrocution hazards.
CPSC•Agiiman Pressure WashersAgiiman pressure washers are recalled due to a lack of GFCI protection, posing a serious risk of electric shock and electrocution.
CPSC•Children's Metal Multi-Point Swing FramesFun and Function is recalling model MW7661 metal swing frames due to a fall hazard caused by the frame cracking or breaking during use.
CPSC•Apex and Manik ATX Computer Power SuppliesApex Gaming PCs is recalling Manik and Apex-branded ATX computer power supplies due to missing electrical shock and electrocution hazard labels.
CPSC•Montessori Airplane Teething ToysMontessori airplane-shaped teething toys are recalled due to a choking hazard posed by the toy's tentacle ends.
CPSC•Le Hao Tool Electric Pressure WashersLe Hao Tool is recalling electric pressure washers due to shock and electrocution hazards caused by the lack of a ground-fault circuit-interrupter.