FDA•MODERATE
Diversatek Viper Balloon Dilator
Diversatek recalls Viper 3-Stage Balloon Dilator (6-7-8mm) due to incorrect inflation tag info.
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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.
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.
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