FDA•LOW
Primidone Tablets 250 mg
American Health Packaging recalls Primidone Tablets 250 mg due to trace Acemetacin contamination.
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FDA•LOWBusulfan InjectionSagent Pharmaceuticals is recalling Busulfan Injection (NDC 25021-241-10) due to failed impurities and degradation specifications.
FDA•LOWPrimidone Tablets 50 mgPrimidone 50 mg tablets recalled due to possible cross-contamination with Acemetacin.
2 products
FDA•LOWPrimidone 250mg TabletsLannett Company is recalling Primidone 250mg Tablets (NDC 0527-1231-01) due to potential cross-contamination with Acemetacin API.
FDA•MODERATEICU Medical Oncology Extension SetICU Medical is recalling Oncology Extension Set REF: CL3960 due to a potential leak that could cause therapy interruption or hazardous exposure.
FDA•CRITICALPS Seasoning & Spices: 6 productsPS Seasoning recalls Ellsworth Sour Cream + Onion Seasoning and other seasonings over Salmonella risk.
6 products
FDA•MODERATETangent Single Use Digital CatheterTangent Endoscopy is recalling single-use digital catheters due to potential fractures at the distal shaft tip.
FDA•MODERATESwan-Ganz Catheters (Multiple Models)Becton, Dickinson and Company is recalling multiple variants of its Swan-Ganz pulmonary artery catheters due to a potential risk of valve leakage that may affect the balloon inflation performance.
3 products
FDA•MODERATEStraus Family Creamery: 5 productsStraus Family Creamery recalls Organic Super Premium Ice Cream over possible metal pieces.
5 products
FDA•CRITICALDOXOrubicin Hydrochloride Liposome InjectionSun Pharma recalls DOXOrubicin Liposome Injection 50 mg/25 mL vials due to glass particulate matter.
FDA•MODERATECodman CerebroFlo EVD CatheterIntegra LifeSciences is recalling the Codman CerebroFlo EVD Catheter due to out-of-specification endotoxin results.
FDA•CRITICALArrow Edge Hemodialysis Catheterization ProductArrow Edge hemodialysis catheterization product recalled: sheath introducer may not split, risking injury.
6 products
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•CRITICALMG217 Multi-Symptom Treatment CreamMG217 Multi-Symptom Treatment Cream recalled due to Staphylococcus aureus contamination.
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•CRITICALNamic Angiographic ManifoldMedline recalls Namic Angiographic Manifolds (SKU 64038200) due to particulate in the fluid path.
14 products
FDA•MODERATEDonJoy IceMan Classic CubeDonJoy IceMan Classic Cube recalled due to broken connector interrupting cold therapy.
4 products
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•MODERATEDuloxetine Delayed-Release Capsules 60mgBreckenridge Pharmaceutical is recalling Duloxetine 60mg capsules distributed nationwide due to the presence of an impurity above FDA limits.
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•CRITICALJOHN B SANFILIPPO & SONS: 6 productsJohn B. Sanfilippo recalls nut mixes over Salmonella risk.
6 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•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•CRITICALGriffith Foods: 3 productsGriffith Foods recalls meatloaf seasoning, milk wash, and milk-n-egg mix due to potential Salmonella.
3 products
FDA•MODERATEPhysio-Control LIFEPAK DefibrillatorsPhysio-Control is recalling various LIFEPAK defibrillators serviced without proper performance inspections, potentially delaying therapy.