FDA•MODERATE
nanOss 3D Advanced Bone Graft Substitute
XTANT Medical is recalling nanOss 3D bone graft substitutes due to an incorrect five-year shelf life label.
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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.
FDA•MODERATEPantoprazole Sodium Delayed-Release Tablets 40 mgCamber Pharmaceuticals is recalling Pantoprazole Sodium 40 mg tablets (NDC 31722-713-10) due to discoloration.
FDA•CRITICALSalute Seasonings Ground All SpiceUnistel recalls Salute Seasonings Ground All Spice 16 oz over Salmonella risk.
FDA•MODERATEMedline Namic GuidewiresMedline recalls Namic syringes, guidewires, and tubing due to rescinded 510(k) clearances.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•MODERATEOlympus Thunderbeat II ShearsOlympus recalls Thunderbeat II Shears (model TB2-0520FC) over distal tip detachment risk.
4 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.
FDA•MODERATEARTIS Pheno VE30A and VE40A Imaging SystemSiemens is recalling ARTIS Pheno VE30A and VE40A imaging systems (Model 10849000) due to unregulated dose causing unintentional low-dose radiation exposure.
FDA•MODERATEDesmopressin Nasal Spray, USP 10 mcg/0.1 mLApotex is recalling Desmopressin Nasal Spray (NDC 60505-0815-0) due to defective bottle caps with missing or dislodged liners.
3 products
FDA•MODERATEBooey's Dragon's Breath SauceBooey's Dragon's Breath sauce recalled for undeclared fish and sesame allergens.
FDA•MODERATEMedline CENTURION Circumcision KitMedline is recalling CENTURION Circumcision Kit (CIT7050F) due to one lot distributed without sterilization.
FDA•MODERATEPhilips Spectral CT on RailsPhilips Spectral CT on Rails (Model 728334) requires a software update to address gantry positioning, message display, and menu option issues.
CPSC•LOWCasely Power Pods Wireless Power BanksCasely is recalling 5000mAh Power Pods wireless chargers due to fire and burn hazards that have caused serious injuries and one fatality.
FDA•MODERATEEpinephrine Injection USP 1 mg/10mLInternational Medication Systems is recalling Epinephrine Injection 1 mg/10mL (NDC 76329-3318-1) due to lack of sterility assurance.
FDA•CRITICALAyco Fresh CantaloupeAyco is recalling whole fresh cantaloupes over potential Salmonella contamination.
FDA•LOWBee Well Wildflower HoneyBee Well is recalling Wildflower Honey in 12, 22, and 44 oz jars over high C4 sugar content.
FDA•MODERATECytal Wound Matrix 2-Layer 5x5 cmCytal Wound Matrix 2-Layer 5x5 cm recalled over out-of-specification endotoxin results.
5 products
FDA•MODERATEReact Health PHOENIX 5L Oxygen ConcentratorReact Health PHOENIX 5L Oxygen Concentrator recalled due to devices not meeting quality specifications.
FDA•CRITICALB. Braun STREAMLINE Bloodline SetB. Braun recalls STREAMLINE bloodline sets for Dialog DR over arterial line air bubble risk.
6 products
FDA•MODERATEElegance Anterior Cervical PlatesClariance-SAS is recalling Elegance Anterior Cervical Plates due to the presence of burrs on the finished product.
2 products
FDA•MODERATERiverence Smoked Trout DipRiverence is recalling Smoked Trout Dip due to an undeclared milk allergen.
FDA•MODERATEClonidine Transdermal System 0.2 mg/dayTeva recalls Clonidine Transdermal System 0.2 mg/day due to CGMP deviations (unapproved raw material).
3 products
FDA•MODERATEHuons: Multiple Rx Only InjectionsHuons recalls injectable lidocaine, bupivacaine, and saline due to sterility concerns.
9 products
FDA•LOWIsland Kinetics: multiple gelsIsland Kinetics recalls hydrocortisone 1% gels (Remedy Gel, Skin Rehab, Essential Calming) due to subpotency.
3 products
FDA•MODERATEAlbuterol Sulfate Inhalation Solution 0.5%Nephron SC recalling Albuterol Sulfate Inhalation Solution (NDC 69374-330-05) due to illegible labeling.
FDA•MODERATEFluocinonide 0.05% Cream 15gTaro recalls Fluocinonide 0.05% Cream 15g tubes due to out-of-spec viscosity.
3 products
FDA•MODERATESemaglutide-Glycine-Cyanocobalamin InjectableNorthwest Compounders is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials due to lack of assurance of sterility.
FDA•MODERATEInstinct Plus Endoscopic Clipping DeviceWilson-Cook Medical is recalling the Instinct Plus Endoscopic Clipping Device due to a potential for the device to malfunction.
FDA•MODERATEPure Palm Medjool DatesPure Palm Medjool Dates recalled due to mislabeling—coconut-covered bites labeled as regular date bites.
3 products
FDA•MODERATEHydroPeptide Clear Alliance SerumHydroPeptide Clear Alliance Serum recalled due to benzene contamination.
4 products
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets over N-Nitroso impurity above acceptable limit.
3 products
FDA•MODERATEExchange Select Honey Lemon Cough DropsExchange Select Honey Lemon Cough Drops recalled over quality concerns from FDA inspection.
15 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•MODERATERemel Yeastone BrothRemel is recalling Yeastone Broth due to the potential for incorrect antimicrobial susceptibility testing results.
FDA•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
- Device RecallFDA•MODERATEPhilips AneurysmFlow Software
Philips is recalling AneurysmFlow software because the MAFA ratio provides unreliable prognostic data for aneurysm treatment decisions.
FDA•MODERATEArjo Tenor Mobile Patient LiftArjo Tenor patient lifts (Models KHA1000 US, KHA1010 US) recalled for actuator failure risk causing sudden arm drop.
FDA•MODERATELanreotide Injection 120 mg/0.5 mLCipla recalls Lanreotide Injection 120 mg/0.5 mL over sterility assurance concerns.
2 products