FDA•MODERATE
Codman CerebroFlo EVD Catheter
Integra LifeSciences is recalling the Codman CerebroFlo EVD Catheter due to out-of-specification endotoxin results.
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FDA•MODERATEBARD Dynamic Deca Steerable CatheterBARD Dynamic Deca Steerable EP catheter recalled due to incomplete seals on sterile product.
26 products
FDA•MODERATEEdwards EVOQUE Tricuspid Delivery SystemEdwards Lifesciences is updating the labeling for the EVOQUE tricuspid delivery system to include a warning about potential functionality issues.
FDA•MODERATECreamy Sesame NoodlesFly By Jing recalls Creamy Sesame Noodles over possible undeclared peanut allergen.
FDA•MODERATEZYMUTEST HIA IgG ELISA KitZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.
FDA•MODERATEPhilips Azurion Cable Hose CarrierPhilips is recalling Azurion imaging systems due to potential loosening or breakage of Cable Hose Carrier bolts and plastic parts.
FDA•MODERATEQuickVue Dipstick Strep A TestQuidel is recalling QuickVue Dipstick Strep A Test (REF 20108) due to risk of false positive results.
FDA•MODERATEThermedx FluidSmart Urology Tube SetStryker is recalling the FluidSmart Urology Tube Set (REF LL0006) due to the distribution of nonconforming products.
FDA•MODERATESelenia Dimensions Mammography SystemsHologic recalls Selenia Dimensions mammography systems over loose or broken internal bolts.
2 products
FDA•MODERATEMetoprolol Succinate Extended-Release Tablets 25 mgAscend Laboratories is recalling 25 mg Metoprolol Succinate Extended-Release Tablets due to failed dissolution testing.
FDA•MODERATEDexcom G7 CGM iOS AppDexcom recalls G7 CGM iOS App (v2.9.0–2.11.2) over glucose alert delays that may cause missed hypo/hyperglycemic events.
4 products
FDA•MODERATEBuprenorphine Hydrochloride Injection 0.3mg/mLEndo USA recalls Buprenorphine Hydrochloride Injection 0.3mg/mL vials (NDC 42023-179-05) due to particulate matter contamination.
FDA•MODERATEDiowave 250W Laser SystemDiowave 250W Laser System recalled; software update needed to correct power output exceeding FDA-cleared 60W limit.
FDA•MODERATELUCAS Chest Compression SystemJolife AB is recalling LUCAS 2, 3, and 3.1 chest compression systems due to missing service documentation.
2 products
FDA•MODERATEOasis Tears PF Lubricant Eye DropsOasis Tears PF eye drops (NDC 42126-6400-1) recalled due to lack of assurance of sterility.
FDA•MODERATEDakota Honey: 5 CompaniesDakota Honey recalls Spreadable Spun Honey varieties over possible metal/plastic contamination.
5 products
FDA•MODERATERevolution Ascend CTGE HealthCare recalls Revolution Ascend CT over AW Server security vulnerability.
7 products
FDA•MODERATEAlain Milliat Orange MarmaladeFinesaler recalls Alain Milliat Orange Marmalade 300g jars over possible glass contamination.
FDA•MODERATEDonJoy IceMan Classic CubeDonJoy IceMan Classic Cube recalled due to broken connector interrupting cold therapy.
4 products
FDA•MODERATEOn-X Mitral Heart Valve with Conform-X Sewing RingOn-X is recalling Model ONXMC-25/33 Mitral Heart Valve due to incomplete testing before distribution.
FDA•MODERATECafe Nouria Blueberry MuffinThe Brownie Baker is recalling Cafe Nouria Blueberry Muffin due to undeclared walnuts, which pose a risk to those with nut allergies.
FDA•MODERATELundberg Family Farms White Jasmine Rice 32 ozLundberg Family Farms recalls White Jasmine Rice 32 oz over possible foreign material contamination.
FDA•MODERATEBioCera Fibers Bone Void FillerOrthorebirth recalls BioCera Fibers bone void filler (REFs ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC) for out-of-spec.
2 products
FDA•MODERATEMedline Convenience KitsMedline is recalling Ancillary Pack-LF and Open Heart Anesthesia ICC-A kits due to potential issues with sterilization and packaging calibration.
58 products
FDA•MODERATEGood & Gather Sesame Teriyaki Chicken with RiceGood & Gather Sesame Teriyaki Chicken with Rice recalled due to undeclared sesame allergen.
FDA•MODERATEDuloxetine Delayed-Release Capsules 60mgBreckenridge Pharmaceutical is recalling Duloxetine 60mg capsules distributed nationwide due to the presence of an impurity above FDA limits.
FDA•MODERATEPublix Bran Flakes Wheat CerealPublix Bran Flakes Wheat Cereal recalled over possible plastic contamination.
FDA•MODERATENaproxen Oral SuspensionAcella Pharmaceuticals is recalling Naproxen Oral Suspension, 125 mg/5mL, distributed nationwide due to lead and lithium contamination.
FDA•MODERATEBioFire Joint Infection PanelBioFire is recalling the Joint Infection (JI) Panel due to contamination that may cause false positive test results.
- Device RecallFDA•MODERATEMint Lesion Software
Mint Medical is recalling Mint Lesion software versions 3.4.0–3.9.5 due to a risk of data loss or incorrect patient information linking.
FDA•MODERATEOne Step 10A in vitro diagnostic testOne Step 10A in vitro diagnostic test recalled for lack of FDA clearance.
7 products
FDA•MODERATEBiofire Spotfire Respiratory/Sore Throat PanelBioFire is recalling the Spotfire Respiratory/Sore Throat Panel due to the risk of false negative results and control failures.
FDA•MODERATEDEX Ophthalmic Tissue ForcepsKatalyst Surgical recalls DEX Ophthalmic Tissue Forceps, model DVF4005-23, due to IFU corrective action.
12 products
FDA•MODERATEJesse Withrow: 2 Glass Mason Jars With Metal LidsMy Wife's Slaw (original and Jalapeno Heat) recalled for lack of approved food establishment inspection.
2 products
FDA•MODERATEVegan Kale Caesar SaladMarket of Choice recalls Vegan Kale Caesar Salad over undeclared sesame allergen.
FDA•MODERATEWinfield's Chocolate BarsWinfield's CWB Chocolate Bars recalled over undeclared milk allergen.
FDA•MODERATEAmoxicillin and Clavulanate Potassium Oral Suspension DropsCronus Pharma is recalling Amoxicillin and Clavulanate Potassium oral suspension drops for dogs and cats due to product discoloration.
2 products
FDA•MODERATEWoodstock Organic Shelled EdamameWoodstock Organic Shelled Edamame recalled over possible metal pieces.
FDA•MODERATEOctreotide Acetate for Injectable SuspensionTeva is recalling Octreotide Acetate 30 mg injection kits due to a lack of assurance of sterility.
2 products
FDA•MODERATEEnalapril Maleate Tablets, USP 20 mgRising Pharma is recalling Enalapril Maleate 20 mg tablets (NDC 64980-688-10) due to failed impurities test.
FDA•MODERATEBD PurPrep Sterile SolutionCareFusion is recalling BD PurPrep sterile solution due to a lack of assurance of sterility and potential product contamination.
2 products
FDA•MODERATEWalker Honey: 10 productsWalker Honey recalls Fain's creamed honey spreads over possible stainless steel and plastic particles.
10 products
FDA•MODERATEHorizon Organic Chocolate Lowfat MilkHorizon Organic recalls Chocolate Lowfat Milk 8-oz boxes due to package integrity issues.
FDA•MODERATE...And Kimchi Kimchi...And Kimchi kimchi recalled for undeclared fish allergen.
FDA•MODERATEDELFLEX Peritoneal Dialysis SolutionFresenius recalls DELFLEX dialysis solution due to potential bag leaks compromising sterility.
2 products
FDA•MODERATEDuloxetine Delayed-Release Capsules 30 mgAjanta recalls Duloxetine 30 mg capsules over nitrosamine impurity above FDA limit.
3 products
FDA•MODERATEXZL Jelly SnacksSungal Inc. recalls XZL Jelly Snacks 12.68 oz bags due to undeclared FD&C Yellow #5, #6, and Red #40.
FDA•MODERATEMontebianco Base VeganMontebianco Base Vegan is recalled due to undeclared milk, which exceeds acceptable levels despite the product's warning label.
FDA•MODERATEPhysio-Control LIFEPAK DefibrillatorsPhysio-Control is recalling various LIFEPAK defibrillators serviced without proper performance inspections, potentially delaying therapy.
FDA•MODERATESecond Nature Keto Crunch Smart MixSecond Nature recalls Keto Crunch Smart Mix 10 oz pouches due to undeclared cashews, pistachios, and dried cherries.