FDA•MODERATE
AMS DSAEK Pack Convenience Kit
Windstone recalls AMS DSAEK Pack kits (Part AMS12394B) due to detached blue BOPs in saline bags.
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FDA•MODERATEMedicaLyte Liquid Bicarbonate ConcentrateNipro recalls MedicaLyte hemodialysis concentrate (REF BC-100, BC+201) over high endotoxin levels.
4 products- Food RecallFDA•MODERATEFannie May & XO Marshmallow Pixie S'mores Collection
Fannie May & XO Marshmallow Pixie S'mores Collection recalled for undeclared milk and pecans.
FDA•LOWPovidone Iodine/Proparacaine Ophthalmic SolutionImprimis NJOF recalls ophthalmic solution for being subpotent, risking reduced efficacy.
FDA•LOWFluphenazine HCl Tablets 1mgAjanta Pharma recalls Fluphenazine HCl 1mg tablets (NDC 27241-255-01) due to impurity out-of-specification.
FDA•MODERATESoft PVC Thoracic CathetersThis recall involves thoracic catheters manufactured for use in draining fluid or air from the chest cavity.
3 products
FDA•MODERATEDermaV Laser SystemLutronic recalls DermaV Laser System over burn risk from spark/loud noise at high fluences.
FDA•MODERATEHeartSine Samaritan PadsSee the official recall notice for details about this display summary.
FDA•MODERATEHalyard IV Start KitAVID Medical recalls Halyard IV Start Kits (REF KRIV26-02) due to sterility concerns with included applicators.
FDA•LOWTrokendi XR (topiramate) Extended-Release CapsulesTrokendi XR (topiramate) 50 mg capsules recalled over failed dissolution specs.
FDA•MODERATEMycophenolate Mofetil for InjectionMylan recalls Mycophenolate Mofetil for injection, 500 mg/vial, over failed dissolution specs.
FDA•MODERATEBD Urinary Catheter Trays with CliniClean Pericare WipesBD Urinary Catheter Trays with CliniClean Pericare Wipes recalled over possible lubricant contamination causing skin irritation.
12 products
FDA•MODERATEGRANUFLO Dry Acid ConcentrateFresenius recalls GRANUFLO Dry Acid Concentrate (0FD2251-3B, 0FD3251-3B) over blue-green discoloration.
3 products
FDA•MODERATEtraZODone Hydrochloride Tablets, USP, 50 mgTeva recalls traZODone HCl 50 mg tablets due to foreign tablets/capsules in product.
FDA•MODERATEFresenius 5008X Blood Tubing SetFresenius recalls 5008X blood tubing set (PN 03-5110-6) over blood leak risk.
4 products
FDA•MODERATEDiscofix Four Way StopcockB Braun recalls Discofix Stopcock Sets over incorrect expiration date on carton label.
- Device RecallFDA•MODERATELUX-Dx Insertable Cardiac Monitor System Software
Boston Scientific recalls LUX-Dx ICM server software (Model 7260) over delayed AF Burden Alerts.
3 products 
FDA•LOWWonton Specialists: 6 productsWonton Specialist recalls noodles and dumpling skins for undeclared FD&C Red No. 40, an allergen risk.
6 products
FDA•MODERATEVelys Enabling Tech Robotic-Assist StationMedos recalls Velys Robotic-Assist Station over software issue causing unintended arm movement.
FDA•MODERATEPooled Cryoprecipitated AHFVitalant recalls Pooled Cryoprecipitated AHF for not meeting specifications.
- Device RecallFDA•MODERATEPhilips Brilliance CT Systems
Philips recalls Brilliance iCT and related CT systems over unintended radiation issue.
4 products 
FDA•MODERATELexia: Multiple Broadway Joe's Pain CreamsLexia LLC recalls Broadway Joe's Pain Cream over potential raw material contamination.
2 products
FDA•MODERATEMedline Convenience Kits with BD ChloraPrep Clear 1mL ApplicatorsMedline recalls Convenience Kits with BD ChloraPrep Clear 1mL Applicators over possible open or incomplete seals.
13 products
FDA•MODERATEBaxter Novum IQ Syringe PumpBaxter recalls Novum IQ Syringe Pump over a software issue during multi-syringe infusions.
2 products
FDA•MODERATEHEALON EndoCoat PRO and DUET PRO IIJ&J Surgical Vision updates instructions for HEALON viscoelastic products used in cataract surgery over cannula insertion risks.
FDA•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedNew York Blood Center Enterprises recalls Apheresis Platelets, Leukocytes Reduced, Irradiated units over excessive platelet count.
FDA•LOWApheresis Red Blood Cells, Leukocytes Reduced, IrradiatedNew York Blood Center recalls apheresis red blood cells over incorrect anticoagulant ratio.
FDA•MODERATEMedline Convenience KitsMedline recalls two convenience kits over sterility breach risk in included BD ChloraPrep and FREPP applicators.
16 products
FDA•MODERATEPrasugrel Tablets 10mgMylan recalls Prasugrel Tablets 10mg over failed dissolution specs.
FDA•MODERATETHE ONE SPF 50 Invisible Sunscreen GelAllies Group recalls THE ONE SPF 50 Invisible Sunscreen Gel over subpotent protection.
4 products
FDA•MODERATEWeis Pasteurized Apple CiderWeis Markets recalls Fresh From the Orchard pasteurized apple cider over high patulin levels.
FDA•LOWDoxylamine Succinate and Pyridoxine HCl Delayed-Release TabletsBionpharma recalls Doxylamine Succinate and Pyridoxine HCl 10 mg/10 mg tablets over foreign tablets or capsules.
FDA•MODERATESTA Staclot Protein SDiagnostica Stago recalls STA Staclot Protein S reagent over QC drift within its 4-hour stability period.
FDA•MODERATEBaxter Healthcare: multiple drugsBaxter recalls 17 sterile injectable drugs, including Vancomycin and Clindamycin, over CGMP deviations.
17 products
FDA•MODERATEHalyard Medical Convenience KitsAVID Medical recalls 80+ Halyard convenience kit variants over endotoxin variability in Ritmed Neurological Sponges.
3 products
FDA•MODERATEApheresis Platelets, PAS, Leukocytes Reduced, Pathogen ReducedRed Cross recalls Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, not tested for pH.
FDA•MODERATEPaxil CR Paroxetine 37.5mg TabletsApotex recalls Paxil CR 37.5mg tablets for failing dissolution specs.
FDA•MODERATEMehadrin Chocolate Leben 6 oz CupsMehadrin Chocolate Leben 6 oz cups recalled due to improper pasteurization.
FDA•MODERATEHorizon Organic Chocolate Milk 8 ozHorizon Organic recalls 1% chocolate milk 8 oz Tetra Paks over potential spoilage.
- Device RecallFDA•MODERATEPortrait Core Services Software V1.1
GE Medical recalls Portrait Core Services Software V1.1 over possible loss of patient monitoring and alarm reset issues.
4 products 
FDA•MODERATERamipril Capsules USP 10 mgHikma recalls Ramipril Capsules USP 10 mg over a failed impurity (DCU) specification.
FDA•MODERATEICU Medical IV Sets with Drip ChambersICU Medical recalls IV sets with drip chambers due to black specks that may delay therapy.
FDA•LOWAfricando Alfredo Hot SauceAfricando Alfredo Hot Sauce recalled for undeclared wheat and soy allergens.
FDA•MODERATEByron White Formulas: 3 May Contain Nuts CasByron White Formulas recalls A-L Complex, A-FNG, and A-P herbal supplements due to undeclared walnuts.
3 products
FDA•MODERATEOlympus PowerSeal 5 mm Curved Jaw Sealer & DividerOlympus recalls PowerSeal 5 mm Curved Jaw Sealer & Divider over labeling error.
FDA•MODERATEZicam Medicated Nasal SwabsZicam nasal swabs recalled over microbiological testing failures.
FDA•MODERATEIMRIS ORT200 Operating Room TableIMRIS recalls ORT200 operating room tables due to actuator/lock failure risk of unintended movement.
2 products
FDA•MODERATEActhar Gel (Repository Corticotropin Injection) 5 mL VialsMallinckrodt recalls Acthar Gel 5 mL vials over glass and stopper particulate.
2 products
FDA•MODERATEClobetasol Propionate Cream USP, 0.05%Lupin recalls Clobetasol Propionate Cream 0.05% due to failed content uniformity.
FDA•MODERATEhealthmark ProChek-II TestHealthmark recalls ProChek-II tests (PT-313, PT-201-12) over expired ingredient risk.
2 products