Device Recall
FDA•MODERATE
3mensio Vascular Fenestrated Workstation Software
3mensio software may report inaccurate cardiovascular measurements when analyzing specific Philips 3D echo datasets.
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FDA•MODERATESilent Nite Sleep ApplianceThe Silent Nite Sleep Appliance (Model SILNT) is being recalled because it lacks required FDA clearance.
FDA•LOWLidolog KitLidolog Kit is being recalled because the label wrap obscures the barcode, making it difficult to scan.
FDA•MODERATEOlympus 4K UHD LCD MonitorOlympus is recalling the 4K UHD LCD Monitor (model OEV321UH) due to a potential connector fault that may cause image loss or abnormalities.
FDA•MODERATEFARADRIVE Steerable Sheath Clear IDEBoston Scientific is recalling the FARADRIVE Steerable Sheath Clear IDE due to potential valve damage that may cause air embolism.
4 products
FDA•MODERATEAVID Medical Eye Pack Convenience KitAVID Medical is recalling the Eye Pack convenience kit (Model LVEY27) due to an incorrect concentration of Betadine solution.
FDA•MODERATESeaSpine Polyaxial HeadSeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach during surgery.
FDA•Zen Principle Moringa Leaf Powder CapsulesZen Principle Moringa Leaf Powder Capsules recalled over possible Salmonella contamination.
FDA•Cetirizine Hydrochloride Tablets 5 mgCetirizine HCl 5 mg tablets recalled over possible Ranitidine cross contamination; lots GY825029–GY825032.
FDA•Ola-Ola Pounded YamFayus recalls Ola-Ola Pounded Yam (2lb–10lb) for undeclared milk allergen.
FDA•Taylor Fresh Foods Iceberg LettuceTaylor Fresh Foods recalls iceberg lettuce under CV, JB, Mark, MKTSD brands due to Cyclospora risk.
CPSC•Cat & Jack Children's SandalsCat & Jack children's sandals are recalled due to a choking hazard from detachable pearls on the footwear.
FDA•MODERATECyproheptadine Hydrochloride SyrupRising Pharma recalls Cyproheptadine HCl Syrup 2mg/5 mL due to crystallization and floating particles.
FDA•MODERATELevothyroxine Sodium 25 mcg TabletsMajor Pharmaceuticals is recalling Levothyroxine Sodium 25 mcg tablets due to subpotency.
12 products
FDA•MODERATEAmlodipine and Olmesartan Medoxomil TabletsAscend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10 mg/20 mg) due to failed dissolution specifications.
FDA•Trokendi XR 25mg CapsulesSupernus Pharmaceuticals is recalling Trokendi XR 25mg capsules due to failed dissolution specifications.
FDA•MODERATEVintage Roots Root Beer SyrupVintage Roots is recalling 8 oz Root Beer Syrup due to the presence of an unapproved food additive, sassafras bark.
FDA•Ascend Laboratories: Multiple Dabigatran Etexilate CapsulesAscend Laboratories is recalling 110 mg and 150 mg Dabigatran etexilate capsules due to failed impurity and degradation specifications.
2 products
FDA•Divalproex Sodium Delayed-Release TabletsBionpharma is recalling 500 mg Divalproex Sodium Delayed-Release Tablets due to the presence of foreign tablets or capsules in the bottles.
FDA•MODERATEFerno Power F2 Powered Fastening SystemFerno is recalling the Power F2 Powered Fastening System due to a risk of the rail mechanism lodging and preventing stretcher movement.
FDA•MODERATEHotline Fluid Warming SetICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.
FDA•MODERATEParagon 28 Phantom Intramedullary Nail System Guide RodParagon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (item P31-955-1800-S) due to sterile packaging breaches.
FDA•MODERATEBoston Scientific FARASTAR PFA GeneratorBoston Scientific is recalling FARASTAR PFA generators (Product ID 61M401) due to incompatibility with the FARAPOINT PFA catheter.
FDA•MODERATEFARASTAR Ablation Generator and Cardiac Ablation CatheterBoston Scientific is recalling FARASTAR Ablation Generators and Cardiac Ablation Catheters due to missing information in the device labeling.
3 products
FDA•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedLifeSouth is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated, due to failure to meet platelet yield specifications.
CPSC•Currey & Company Nottaway ChandeliersCurrey & Company is recalling Nottaway chandeliers due to an electrocution hazard caused by a lack of proper electrical grounding.
CPSC•Hollis 200LX Diving RegulatorsHollis 200LX diving regulators are recalled due to a risk of drowning from potential inlet tube breakage.
CPSC•Jobon Torch LightersJobon torch lighters are recalled for lacking child-resistant mechanisms, posing fire and burn hazards to users.
CPSC•Liizousuda Paint ThinnerLiizousuda paint thinner is recalled because its non-child-resistant packaging poses a poisoning and chemical pneumonia risk to children.
CPSC•Madewell Women's SweatersMadewell is recalling women's sweaters due to a violation of federal clothing textile standards, posing a serious burn and injury risk.
CPSC•MNIENT Adult Portable Bed RailsMNIENT adult portable bed rails (model LQX-110055) are recalled due to serious entrapment, asphyxiation, fall, and laceration hazards.
CPSC•Noerishia Adult Portable Bed RailsNoerishia adult portable bed rails are recalled due to a serious entrapment and asphyxiation hazard.
CPSC•Oitnlaughter LED Finger Light ToysOitnlaughter LED finger lights are recalled due to a battery ingestion hazard that can cause serious injury or death.
CPSC•Panasonic Electric Toaster OvensPanasonic is recalling model NB-G200 electric toaster ovens due to shock and fire hazards from insufficient power cord insulation.
CPSC•SDADI Kitchen Step StoolsSDADI kitchen step stools are recalled due to collapse, tip-over, and entrapment hazards that pose a risk of serious injury or death.
CPSC•Boon PIVOT Toddler Tower Step StoolsBoon PIVOT toddler tower step stools are being recalled due to tip-over and fall hazards that pose a risk of serious injury or death.
CPSC•Wade Logan Annyka 9-Drawer Fabric DressersWade Logan 9-drawer fabric dressers are recalled due to tip-over and entrapment hazards that violate federal safety standards.
CPSC•Flashgitz Relic Lunch Box Copper CupsCopper cups in Flashgitz Space King Relic Lunch Boxes are recalled due to lead poisoning hazards.
FDA•MODERATETosoh ST AIA-Pack TestosteroneTosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
FDA•Khong Guan Glutinous Rice Balls with Black Sesame FillingKhong Guan expands recall of glutinous rice balls with black sesame filling due to undeclared peanuts.
FDA•MODERATEBD ChloraPrep Clear ApplicatorsCareFusion is recalling BD ChloraPrep Clear sterile solution applicators due to a potential lack of sterility from incomplete packaging seals.
FDA•MODERATEPhotera 400 Phototherapy DeviceDaavlin recalls Photera 400 phototherapy device due to incorrect UV sensor GAIN causing wrong output.
3 products
FDA•MODERATEMedline Total Knee Pack DYNJT6267Medline recalls Total Knee Pack DYNJT6267 over sterility breach risk from Zimmer Biomet mixing bowls and spatulas.
2 products
FDA•MODERATEVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemVasoview Hemopro 2 Endoscopic Vessel Harvesting System is recalled due to an out-of-specification sterilization dose.
FDA•MODERATEMedtronic DLP One-Piece Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material risk.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic recalls Replacement Brush Heads model Papablic18B due to breakage risk.
2 products
FDA•MODERATECleviprex Injectable EmulsionChiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.
FDA•MODERATEAmy's Organic Lentil Soup Light in SodiumAmy's is recalling 14.5 oz cans of Organic Lentil Soup Light in Sodium due to potential spoilage.
FDA•MODERATEOla-Ola Pounded GroundnutsOla-Ola Pounded Groundnuts are recalled due to undeclared peanuts, posing a risk to consumers with peanut allergies.
FDA•MODERATEBell Pharmaceuticals: Multiple Carbamide Peroxide ProductsBell Pharmaceuticals recalls store-brand carbamide peroxide ear drops for subpotency (low pH, ~0.6% assay).
11 products