FDA•MODERATE
Olympus Thunderbeat II Shears
Olympus recalls Thunderbeat II Shears (model TB2-0520FC) over distal tip detachment risk.
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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•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.
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•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•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•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•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
FDA•MODERATEOmnipaque (iohexol) Injection 350 mg/mLGE Healthcare recalls Omnipaque (iohexol) Injection 350 mg/mL due to particulate matter.
2 products
FDA•MODERATEStryker Sustainability Solution Tourniquet CuffsStryker is recalling tourniquet cuffs that may detach from the bladder, preventing the device from maintaining pressure.
FDA•MODERATECrab CakesConnecticut Crab Co. recalls crab cakes over possible temperature abuse and botulism risk.
FDA•MODERATEImu-Tek Animal Health: 2 productsImu-Tek recalls Colostrum-5 capsules and powder due to under-processing.
2 products
FDA•MODERATEReadyMeals Turkey Bacon & Cheddar Pretzel Duo SandwichF&S Fresh Foods recalls ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwiches over undeclared sesame.
FDA•MODERATEDivided Sunset Multi Collagen PeptidesDivided Sunset Multi Collagen Peptides are recalled for failing to declare egg and fish allergens on the product label.
FDA•MODERATEXanax XR Alprazolam 3 mg TabletsViatris is recalling Xanax XR 3 mg tablets (NDC 58151-506-91) due to failed dissolution specifications.
FDA•MODERATEIsotretinoin Capsules, USP, 40 mgTeva is recalling 40 mg Isotretinoin Capsules due to potency issues.
2 products
FDA•MODERATEB.R.A.H.M.S PlGF Plus KRYPTORBrahms recalls PlGF Plus KRYPTOR test (REF 859075N) due to QC underestimation risk causing false preeclampsia risk classification.
FDA•MODERATEVancomycin HCl 1.5g in 250mL Sodium Chloride InjectionFagron recalls Vancomycin HCl 1.5g/250mL injection due to sterility concern.
5 products
FDA•MODERATEGeri-Care Artificial Tears Lubricant Eye DropsGeri-Care Artificial Tears Lubricant Eye Drops (0.5 oz, NDC 68788-7266-0) recalled due to lack of sterility assurance.
FDA•MODERATEARTIS pheno and ARTIS Icono Biplane X-ray SystemSiemens is recalling ARTIS pheno and ARTIS Icono X-ray systems (Models 10849000, 11327600, 11328100, 11327700) due to erroneous dose display during patient exams.
FDA•MODERATESpacelabs Multi-parameter Command Module Model 91496Spacelabs is recalling Model 91496 Multi-parameter Command Module due to circuit board issue causing inaccurate cardiac output readings.
FDA•MODERATELIQUID BLENZ: 13 productsLiquid Blenz recalls 13 herbal tonics and bitters over under-processing, risking botulism.
13 products
FDA•MODERATECook Arterial Pressure Monitoring TrayCook recalls Arterial Pressure Monitoring Trays due to incorrect expiration dates.
19 products
FDA•MODERATESee Luer Cap Set MPC-130Molded Products is recalling See Luer Cap Set MPC-130 due to threaded sleeve detachment risk.
FDA•MODERATEZarlengo Italian Ice: 5 White Round Food And Freezer GradesZarlengo's recalls Chocolate Gelato (multiple sizes) over undeclared soy allergen.
5 products
FDA•MODERATEFresenius Kabi: Multiple Sale NDC Number InjectionsFresenius Kabi recalls 14 lots of Sodium Chloride and Dextrose Injections due to sterility concerns.
14 products
FDA•MODERATEXTANT MEDICAL Xpress Pedicle Screw SystemXTANT MEDICAL is recalling Xpress Pedicle Screw System 6.5 x 50 mm (X073-6555-DL) due to mislabeling identifying incorrect screw length.
FDA•MODERATETornier HRS Max Tuberosity Body and Trial PartsTornier is recalling shoulder system components incorrectly labeled as HRS Max parts, as they are incompatible with the HRS Max system.
FDA•MODERATESmart & Simple Turmeric PelletsSmartPak Equine is recalling Smart & Simple Turmeric Pellets for horses due to elevated aflatoxin levels.