FDA•MODERATE
HydroMARK Breast Biopsy Site Marker
Devicor Medical is recalling HydroMARK breast biopsy site markers due to incorrect inner package labeling.
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All Recalls
Back to home ←- Device RecallFDA•MODERATEGE HealthCare CARESCAPE Telemetry Server V5
GE HealthCare is recalling CARESCAPE Telemetry Server V5 units due to a risk of losing ECG and SpO2 monitoring capabilities.
6 products 
FDA•MODERATECASE v7.0 Cardiac Testing SystemGE Medical Systems is recalling the CASE v7.0 Cardiac Testing System due to a risk of electrical sparking and potential paper ignition.
FDA•MODERATEMedrad Avanta Injection System Tube SetsBayer is recalling Avanta Multi-Patient Administration Tube Sets due to a connection issue that may cause procedure interruptions.
FDA•MODERATEDa Vinci 5 NIR Handheld CameraIntuitive Surgical is recalling the da Vinci 5 NIR handheld camera system due to a risk of unintentional activation during surgery.
FDA•MODERATEiVIZIA Sterile Lubricant Eye DropsThea Pharma is recalling iVIZIA Sterile Lubricant Eye Drops due to a lack of assurance of sterility.
2 products
FDA•MODERATECalypso Tropic Tango LemonadeKing Juice is recalling Calypso Tropic Tango Lemonade (16 fl oz) due to undeclared Yellow No. 5.
CPSC•LOWLil Pick Up Rex110 and Sierra110 Youth ATVsLil Pick Up recalls 4,900 Rex110 and Sierra110 youth ATVs over crash hazard, suspension defects, and burn risk from hot footwell surfaces.
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•MODERATEJoint Nourish Liquid SupplementWellnov Supplements is recalling Joint Nourish liquid supplement due to potential bacterial contamination and C. botulinum concerns.
14 products
FDA•MODERATEOneLIF Interbody CageNovapproach Spine is recalling 60+ variants of OneLIF Interbody Cages due to a risk of inserter attachment failure during surgery.
2 products
FDA•MODERATESilastic Foley CathetersC.R. Bard is recalling Silastic Brand Foley Catheters due to surface staining on the devices.
FDA•MODERATECovidien Mon-a-Therm Esophageal StethoscopeCovidien is recalling Mon-a-Therm Esophageal Stethoscopes with Temperature Sensors because the devices lack FDA clearance.
3 products
FDA•MODERATEArvis Hip & Knee 3.0 Instrument Set ComponentsKico Knee Innovation is recalling Arvis Hip & Knee 3.0 instrument components over potential wear or corrosion on the magnet face.
2 products
FDA•MODERATESharpoint Microsurgical KnifeSurgical Specialties Corporation is recalling mislabeled Sharpoint microsurgical knives that contain 3.0mm blades instead of 2.2mm.
FDA•MODERATEBD PurPrep Sterile SolutionCareFusion is recalling BD PurPrep sterile solution applicators distributed nationwide due to potential contamination and sterility concerns.
2 products
FDA•MODERATEBioFire Joint Infection PanelBioFire is recalling Joint Infection (JI) Panel test kits due to contamination that may lead to false positive results.
FDA•MODERATEExacta Mix Vented Micro-Volume InletBaxter is recalling Exacta Mix Vented Micro-Volume Inlets (Model H938175) due to incorrect filters that may cause clinical complications.
FDA•MODERATESystane Lubricant Eye GelAlcon is recalling Systane Lubricant Eye Gel due to a lack of assurance of sterility, which may impact product quality.
2 products
FDA•MODERATEWoodstock Organic Shelled EdamameWoodstock Organic Shelled Edamame (10 oz. and 48 oz.) recalled for metal pieces.
FDA•MODERATEDuloxetine Delayed-Release Capsules USP 60mgBreckenridge Pharmaceutical recalls Duloxetine 60mg capsules (NDC 51991-748-90) due to elevated N-nitroso impurity from manufacturing deviations.
FDA•MODERATEFrederik's by Meijer Vanilla Bourbon Trail MixFerris Coffee and Nut Company is recalling 9 oz bags of Vanilla Bourbon Trail Mix due to undeclared wheat and soy allergens.
FDA•MODERATEMedtronic GUNDRY Retrograde CannulaMedtronic is recalling GUNDRY Retrograde Cannula catheters due to a potential sterile barrier breach.
9 products
FDA•MODERATEMAC 5 Resting ECG Analysis SystemsGE is recalling MAC 5 A4 and A5 ECG systems due to a software error that may incorrectly associate clinical data with the wrong patient.
FDA•MODERATEOptase Dry Eye Intense DropsScope Health is recalling Optase Dry Eye Intense Drops (0.33 fl oz, NDC 72972-002-01) due to lack of assurance of sterility.
FDA•MODERATEMy Mochi Strawberry Non-Dairy Frozen DessertThe Mochi Ice Cream Company is recalling Strawberry Non-Dairy Frozen Dessert due to a foreign object found in a retail container.
FDA•MODERATENaproxen Oral Suspension USP 125 mg/5mLAcella Pharmaceuticals is recalling Naproxen Oral Suspension 125 mg/5mL (NDC 42192-619-16) due to lead and lithium contamination above specification.
FDA•MODERATEUncle Giuseppe's Marketplace Milk Chocolate Bridge MixUncle Giuseppe's Marketplace Milk Chocolate Bridge Mix is recalled for undeclared cashews, milk, and soy allergens.
FDA•MODERATEShimadzu Medical Systems X-Ray and Angiography GeneratorsShimadzu is recalling 20+ models of X-ray and angiography systems due to a contactor defect that may keep power active when switched off.
FDA•MODERATEFreshKote Lubricant EyedropsHarrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.
FDA•MODERATENegita Cracker ShrimpHadson is recalling Negita Cracker Shrimp 2.8 oz over undeclared FD&C Yellow 6.
FDA•LOWLevocarnitine Injection, USP 1 g/5 mLAmerican Regent is recalling Levocarnitine Injection 1 g/5 mL vials (NDC 0517-1045-01) due to missing label.
CPSC•LOWCasely Power Banks 5000mAh MagSafe Wireless ChargerCasely recalls 5000mAh Power Banks (model E33A) over lithium-ion battery fire risk; one fatality reported.
FDA•MODERATEPublix Bran FlakesPublix Bran Flakes are being recalled due to the potential presence of plastic foreign material.
- Food RecallFDA•MODERATESilver Moon LP: 48 recalled products
48 Silver Moon LP products recalled over tree nuts, peanuts, milk, eggs, soy, wheat, sulfites, and other hazards.
48 products 
FDA•MODERATECovidien Shiley Tracheostomy TubeCovidien is recalling Shiley Tracheostomy Tubes (REF 6FEN) due to incorrect display box labeling.
FDA•MODERATECovidien EndoStitch Polysorb Single Use Loading UnitCovidien is recalling EndoStitch Polysorb loading units (models 170053 and 170071) due to a compromised sterile barrier.
FDA•LOWMonsel's Ferric Subsulfate Solution 8 mLPremier Dental Products is recalling Monsel's Ferric Subsulfate Solution 8 mL vials (NDC 48783-112-08) due to incorrect expiration date on the vial label.
FDA•MODERATEPhilips Achieva 1.5T MR Elastography SystemPhilips is recalling Achieva 1.5T MRE systems due to a software error that may cause inaccurate stiffness value measurements.
19 products
FDA•MODERATESpecially SELECTED Vanilla Creme BruleeLactalis Canada is recalling Specially SELECTED Vanilla Creme Brulee (3.6 oz) over possible glass contamination.
FDA•MODERATEDexcom G7 CGM iOS AppDexcom is recalling G7 CGM iOS app versions 2.9.0–2.11.2 due to a software defect that may delay glucose alerts and readings.
4 products
FDA•MODERATE52USA Strawberry Popping Boba52USA Strawberry Popping Boba is recalled for containing unapproved food colors including FD&C Yellow 5, Yellow 6, and Red 40.
6 products
FDA•LOWBuspirone Hydrochloride Tablets 5 mgUnichem is recalling 500-count bottles of Buspirone Hydrochloride Tablets, 5 mg, due to subpotency.
FDA•MODERATEPhysio-Control LIFEPAK DefibrillatorsPhysio-Control is recalling various LIFEPAK defibrillators due to missing documentation of required performance inspections.
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•MODERATESwad Orange Flavored Masala CandyRaja Foods is recalling Swad Orange Flavored Masala Candy due to undeclared FD&C Yellow 6.
2 products
FDA•MODERATEHalyard Purezero Ultraviolet Nitrile Exam GlovesHalyard is recalling Purezero Ultraviolet Nitrile Exam Gloves due to a failure to meet chemical permeation performance specifications.
FDA•MODERATECodman CerebroFlo EVD CatheterIntegra LifeSciences is recalling the CerebroFlo EVD Catheter due to out-of-specification endotoxin results.
FDA•MODERATEBard Dynamic Deca Steerable Electrophysiology CatheterStryker is recalling Bard Dynamic Deca Steerable Electrophysiology Catheters due to incomplete sterile packaging seals.
26 products
FDA•MODERATEMedline Eye Tray-LF Convenience KitMedline is recalling Eye Tray-LF kits containing mislabeled Cardinal Health syringes that may lead to incorrect insulin dosing.