FDA•CRITICAL
DOXOrubicin Hydrochloride Liposome Injection
Sun Pharma recalls DOXOrubicin Liposome Injection 50 mg/25 mL vials due to glass particulate matter.
Filters
Category
Agency
Severity
Date
Distributed in
All Recalls
Back to home ←
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FDA•MODERATEZYMUTEST HIA IgG ELISA KitZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.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•CRITICALGeorge J Howe: 6 productsGeorge J Howe recalls sunflower seed products due to undeclared cashew allergen.
6 products
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•CRITICALJCB Flavors: 11 productsJCB Flavors recalls seasonings over Salmonella risk.
11 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•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•CRITICALAmerican Contract Systems Coronary Angio PackAmerican Contract Systems is recalling Coronary Angio Packs due to a syringe adaptor defect that may cause disconnection and serious injury.
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•CRITICALUtz Quality Foods: Zapp's and Dirty Potato ChipsUtz is recalling Zapp's and Dirty potato chips in several varieties for possible Salmonella contamination.
6 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•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.
FDA•LOWBuspirone Hydrochloride TabletsUnichem is recalling 5 mg buspirone hydrochloride tablets due to subpotency, which may reduce the medication's effectiveness.
FDA•MODERATESpacelabs Ultraview SL Command ModuleSpacelabs is recalling the Ultraview SL Command Module due to a manufacturing issue with the electrical leakage tester.
2 products
FDA•MODERATEProdisc C SK Cervical Disc ImplantCentinel Spine recalls Prodisc C SK cervical disc implants due to labeling mix-up (5mm/6mm).
2 products
FDA•CRITICALCook Centimeter Sizing CatheterCook recalls Centimeter Sizing Catheter (RPN N5.0-35-100-P-10S-PIG-CSC-20) over marker band cracking risk.
3 products
FDA•MODERATEBoston Scientific LUX-DX II Arrhythmia DetectorBoston Scientific recalls LUX-DX II Arrhythmia Detector (M302) with LATITUDE DRAGON US Server (6460) over missing PVC Burden and Bradyarrhythmia monitoring.
2 products