FDA•MODERATE
AVID Medical Eye Pack Convenience Kit
AVID Medical is recalling the Eye Pack convenience kit (Model LVEY27) due to an incorrect concentration of Betadine solution.
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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.
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.
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
FDA•MODERATEWY Duck Sauce PacketsW.Y. Industries is recalling 0.35 oz. packets of WY Duck Sauce due to potential metal fragment contamination.
FDA•MODERATEOrthofix MINIRAIL Standard LengthenerOrthofix recalls MINIRAIL Standard Lengthener Model M101 due to incorrect labeling.
8 products
FDA•MODERATERuby Quartered Artichoke HeartsRuby Quartered Artichoke Hearts are being recalled due to potential glass contamination.
FDA•CRITICALD'Dioses Fruit Pops: multiple undeclared allergens32 D'Dioses Fruit Pops products recalled for undeclared tree nuts or milk.
32 products
FDA•MODERATEWinfield's CWB Chocolate BarsWinfield's CWB Chocolate Bars recalled for undeclared milk allergen.
FDA•Khong Guan Glutinous Rice Balls with Black Sesame FillingKhong Guan recalls Glutinous Rice Balls with Black Sesame Filling due to undeclared peanuts.
FDA•MODERATEPillsbury Bread Rolls: Hard Roll Dough and Kaiser Roll DoughGeneral Mills is recalling Pillsbury Hard and Kaiser roll dough products due to potential glass contamination.
2 products
FDA•MODERATENystatin Cream USPPadagis is recalling 15 g tubes of Nystatin Cream USP due to subpotent drug results found during stability testing.
FDA•MODERATEOptima XR200amx Radiographic SystemGE HealthCare recalls Optima XR200/220/240amx systems over risk of X-ray arm drop causing injury.
3 products
FDA•MODERATENutricia North America: 2 productsNutricia recalls Liquid Hope and Nourish organic meal replacements due to subpotent vitamin A.
2 products
FDA•MODERATEBoston Scientific Rapid Refill Continuous Injection SystemBoston Scientific is recalling the Rapid Refill Continuous Injection System due to a risk of syringe disconnection during use.
FDA•MODERATEICU Medical Plum Duo Infusion PumpICU Medical recalls Plum Duo Infusion Pump v1.2.3 due to risk of delivering up to twice the programmed volume.
2 products
FDA•CRITICALAbiomed Impella Introducer KitOscor recalls Abiomed Impella Introducer Kits (REF 0052-3025) due to sheath leakage risk.
3 products
FDA•CRITICALTransvenous Pacing Electrode TrayArgon Medical recalls pacing electrode trays over non-sterile lidocaine ampules.
6 products
FDA•CRITICALABIOMED Impella RP Flex Introducer SheathAbiomed recalls Impella RP Flex pump sets over introducer sheath leakage risk.
13 products
FDA•MODERATEOlympus Toomey Evacuator 30cc with AdaptorOlympus recalls Toomey Evacuator 30cc with Adaptor, Model 188, over sterilization concerns.
4 products
FDA•MODERATEVersius Surgeon ConsoleCMR Surgical is recalling the Versius Surgeon Console due to a cybersecurity risk involving the Secure Boot feature.
- Device RecallFDA•MODERATETMINI Miniature Robotic System Tracking Arrays
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays because a loose knob may cause surgical misalignment.
FDA•MODERATEVitek 2 AST-N447 Test KitBiomerieux is recalling Vitek 2 AST-N447 Test Kits due to potential for false resistant results caused by pouch foil fractures.