FDA•MODERATE
Geri-Care Artificial Tears Lubricant Eye Drops
Geri-Care Artificial Tears Lubricant Eye Drops (0.5 oz, NDC 68788-7266-0) recalled due to lack of sterility assurance.
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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•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•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•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•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.
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•MODERATECytal Wound Matrix 2-LayerIntegra LifeSciences is recalling Cytal Wound Matrix 2-Layer 5x5 cm dressings due to out-of-specification endotoxin results.
5 products- Device RecallFDA•MODERATEPhilips AneurysmFlow Software
Philips is recalling AneurysmFlow software due to unreliable MAFA ratio data that may lead to incorrect clinical decisions.
- Device RecallFDA•MODERATELeksell Vantage Arc System
Elekta is recalling the Leksell Vantage Arc System due to a defect in the locking mechanism that may cause coordinate shifting during procedures.
FDA•MODERATEMedline Neuro SpongesMedline is recalling various neuro sponges due to higher-than-expected endotoxin levels.
38 products
FDA•MODERATEDonJoy IceMan Classic3 Cold Therapy UnitDJO is recalling the IceMan Classic3 cold therapy unit (Model 11-0494) due to a broken connector that may interrupt cold therapy.
4 products
FDA•MODERATEDiversatek Healthcare Viper 3-Stage Fixed Wire Balloon DilatorDiversatek Healthcare is recalling the Viper 3-Stage Fixed Wire Balloon Dilator due to incorrect labeling of balloon sizes and pressures.
4 products
FDA•MODERATEBromfenac Ophthalmic Solution 0.07%Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.07% (NDC 62332-583-03) due to failed impurities and degradation specifications.
FDA•LOWRemedy Gel Hydrocortisone 1%Island Kinetics is recalling Remedy Gel hydrocortisone 1% due to subpotency.
3 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•MODERATEOctreotide Acetate for Injectable SuspensionTeva is recalling Octreotide Acetate for Injectable Suspension due to a lack of assurance of sterility.
6 products
FDA•MODERATECurosurf (poractant alfa) 240 mg Intratracheal SuspensionChiesi USA is recalling Curosurf 240 mg intratracheal suspension vials (NDC 10122-510-03) due to lack of sterility assurance.
FDA•MODERATEXanax XR Alprazolam 3 mg TabletsViatris is recalling Xanax XR 3 mg tablets (NDC 58151-506-91) due to failed dissolution specifications.
FDA•MODERATEStraumann Custom Abutment TiStraumann is recalling custom abutments manufactured with incorrect raw material.
2 products
FDA•MODERATEAlbuterol Sulfate Inhalation Solution 0.5%Nephron SC recalling Albuterol Sulfate Inhalation Solution (NDC 69374-330-05) due to illegible labeling.
FDA•MODERATELucerne 2% Cottage CheeseAlbertsons is recalling Lucerne 2% Cottage Cheese due to potential contamination with metal fragments.
FDA•LOWPopping Boba RTD Mixed Berry Hibiscus TeaPocas International is recalling Popping Boba RTD Mixed Berry Hibiscus Tea due to a packaging integrity issue.
4 products
FDA•MODERATEMeclizine Hydrochloride Tablets 12.5 mgAmerican Health Packaging is recalling Meclizine Hydrochloride 12.5 mg tablets (NDC 60687-775-65 and 60687-775-11) due to failed tablet specifications.
FDA•MODERATECinacalcet Hydrochloride TabletsCipla is recalling Cinacalcet Hydrochloride Tablets due to the presence of N-Nitroso Cinacalcet above acceptable limits.
3 products