FDA•MODERATE
Mesh Style Tip Protectors
Healthmark Industries is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) due to a lack of FDA clearance.
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FDA•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
FDA•MODERATEiLet Bionic PancreasBeta Bionics is recalling iLet Bionic Pancreas (software 1.4.2–1.4.3) for Dexcom G7 compatibility issues that may disable glucose correction dosing.
FDA•MODERATETETAS Mireya Cherry Milkshake PopsicleASUKAR FOODS CORP is recalling TETAS Mireya Cherry Milkshake popsicles (UPC 83822654822) due to undeclared soy lecithin.
FDA•MODERATE0.9% Sodium Chloride Injection, USPFresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP, 250 mL bags due to a lack of assurance of sterility.
14 products
FDA•MODERATEB Braun Infusion Pump Administration SetsWindstone Medical Packaging is recalling Pre Op Kits containing B Braun IV administration sets due to potential medication backflow or priming issues.
3 products
FDA•MODERATEMedtronic Sphere-9 Cardiac Ablation CatheterMedtronic Sphere-9 Catheter (Model AFR-00001) may cause ventricular fibrillation in patients with Biotronik ICDs or CRT-Ds during radiofrequency ablation therapy.
FDA•MODERATEArrow Echogenic Introducer NeedleArrow is recalling the Echogenic Introducer Needle due to a manufacturing error involving the device's liquid adhesive.
13 products
FDA•MODERATEHorizon Organic Chocolate Lowfat MilkHorizon Organic is recalling chocolate lowfat milk in 8-oz cartons due to compromised package integrity.
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•MODERATEArjo Tenor Mobile Patient LiftArjo Tenor patient lifts (Models KHA1000 US, KHA1010 US) recalled for actuator failure risk causing sudden arm drop.
FDA•MODERATEPan de Bono Cheese BreadSouth Florida Food recalling Pan de Bono Cheese Bread (14.4 lb boxes) due to undeclared soy.
FDA•MODERATEIcosapent Ethyl Capsules, 1 gramZydus Pharmaceuticals is recalling Icosapent Ethyl Capsules (NDC 70710-1592-7) due to oxidized ingredient causing red dots and melted capsules.
FDA•MODERATEnanOss 3D Advanced Bone Graft SubstituteXTANT Medical is recalling nanOss 3D bone graft substitutes due to an incorrect five-year shelf life label instead of the validated four years.
FDA•MODERATEMilestone Vacuum Bag SU Large Specimen ContainerMilestone is recalling Vacuum Bag SU Large specimen containers (Model 68409SS) due to possible reagent leakage.
FDA•MODERATELSL Healthcare Central Line Dressing KitLSL Healthcare is recalling Central Line Dressing Kits (Model 2717H) due to the inclusion of non-sterile alcohol prep pads.
6 products
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•MODERATESiemens ARTIS pheno X-Ray SystemSiemens is recalling the ARTIS pheno x-ray system (Model 10849000) because it may incorrectly display an x-ray dose of zero during use.
2 products
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•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•MODERATESemaglutide-Glycine-Cyanocobalamin InjectableNorthwest Compounders is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials due to lack of assurance of sterility.
FDA•MODERATECUSA Clarity C7000 ConsoleIntegra LifeSciences is recalling CUSA Clarity C7000 Console (Software 2.1.1.909) due to unresponsive touch screen.
FDA•MODERATEVegetable DumplingsJFE Franchising is recalling Vegetable Dumplings over potential glass contamination.
7 products
FDA•MODERATEBrimonidine Tartrate/Timolol Maleate Ophthalmic SolutionApotex is recalling Brimonidine Tartrate/Timolol Maleate eye drops (NDC 60505-0589-1) due to lack of sterility assurance.
FDA•MODERATECook Medical Arterial Pressure Monitoring TrayCook Medical is recalling Arterial Pressure Monitoring Trays because the labeled expiration dates exceed the device's actual shelf life.
19 products
FDA•MODERATETornier HRS Max Tuberosity Bodies and TrialsTornier is recalling mislabeled shoulder replacement components that are incompatible with the HRS Max system.
FDA•MODERATEVue Motion V12 Imaging SystemPhilips Vue Motion V12 (1017979) may display image frames out of sequence during dynamic imaging runs.
FDA•MODERATEBiDop 3 Pocket DopplerKoven Technology is recalling the BiDop 3 Pocket Doppler because its labeling includes an uncleared fetal indication for use.
2 products
FDA•MODERATEMontebianco Base VeganDisaronno is recalling Montebianco Base Vegan (SKU 113542) due to undeclared milk allergen exceeding safe levels.
FDA•MODERATEAjinomoto Vegetable & Edamame DumplingsAjinomoto is recalling Green Gyoza Vegetable & Edamame Dumplings due to potential glass contamination.
11 products
FDA•MODERATETemozolomide Capsules 5mgRising Pharmaceuticals is recalling Temozolomide Capsules 5mg (NDC 16571-816-51) due to failed impurities and degradation specifications.
FDA•MODERATEArtificial Tears Sterile Lubricant Eye DropsK.C. Pharmaceuticals is recalling various brands of Artificial Tears eye drops nationwide due to a lack of assurance of sterility.
15 products
FDA•MODERATEPhilips Allura Xper FD20 Biplane X-Ray SystemPhilips is recalling Allura Xper FD20 Biplane X-ray systems due to potential wired foot switch failure during imaging.
22 products
FDA•MODERATEOXOID Microbact 12L Listeria Identification KitOxoid is recalling Microbact 12L Listeria Kit (MB1128A, Lot 4494873) due to risk of incorrect organism identification from ambiguous color reactions.
FDA•MODERATEFarmhouse Fresh Midnight Clearing Night LotionFarmhouse Fresh is recalling Midnight Clearing Night Lotion acne treatment due to benzene contamination.
4 products
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•MODERATESoft-Vu Angiographic CatheterAngiodynamics is recalling Soft-Vu angiographic catheters due to a manufacturing defect that may block the catheter hub.
20 products
FDA•MODERATEChina Noodle Co. Steam NoodlesChina Noodle Co. Steam Noodles are recalled due to undeclared wheat, a potential allergen risk for consumers.
4 products
FDA•MODERATEChildren's Ibuprofen Oral Suspension 100 mg/5mLTaro Pharmaceuticals is recalling Children's Ibuprofen Oral Suspension 100 mg/5mL (120 mL) due to gel-like masses and black particles.
FDA•MODERATEeTRAX Needle System Starter KitCivco is recalling the eTRAX Needle System Starter Kit 18G due to a risk of incorrect needle tip positioning on the user interface.
8 products
FSIS•MODERATEPunahele Jerky Company Beef CrispsPunahele Jerky Company beef crisps (6-oz and 4-oz packages) contain undeclared soy lecithin allergen; best-by date Feb 17, 2027 or prior.
FDA•MODERATESavannah Bee Company Honey BBQ Sauce MustardSavannah Bee Company is recalling Honey BBQ Sauce Mustard due to undeclared wheat and soy allergens caused by a mislabeling error.
FDA•MODERATEDivided Sunset Multi Collagen PeptidesDivided Sunset Multi Collagen Peptides are recalled for undeclared egg and fish allergens.
FDA•MODERATESIGNA Premier MR Scanner Magnet FittingsGE Healthcare is recalling SIGNA Premier MR scanners due to ferrous magnet fittings that could cause personnel injury during service.
FDA•MODERATEOlympus SOLTIVE Premium Laser SystemOlympus is recalling the SOLTIVE Premium Laser System due to a power supply defect that may cause inoperability, smoke, or a burning smell.
2 products
FDA•MODERATECardinal Health Monoject Tuberculin Syringe 1 mLCardinal Health is recalling Monoject Tuberculin Syringes (Catalog 1180100777) that contain U-100 insulin syringes instead, risking dosing errors.
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•MODERATEMedline Convenience Kits with 10mL SyringesMedline is recalling 10+ convenience kits containing 10mL syringes due to unapproved design changes.
21 products
FDA•MODERATEPepsin 1:3000 PowderAmerican Laboratories is recalling 50 kg drums of Pepsin 1:3000 Powder due to potential Salmonella contamination.
3 products