FDA•MODERATE
Great Value Hawaiian Roll 4pk
Great Value Hawaiian Roll 4pk recalled over oily substance on food-contact packaging; product never reached store shelves.
Filters
Category
Agency
Severity
Date
Distributed in
All Recalls
Back to home ←
FDA•MODERATERitmed Neurological SpongesAMD Medicom recalls Ritmed Neurological Sponges due to elevated endotoxin risk; full REF list on FDA page.
2 products
FDA•MODERATEdirectCHECK ACT-LR Whole Blood Quality ControlAccriva Diagnostics is recalling directCHECK ACT-LR whole blood quality control, level 2, due to incorrect performance range labeling.
FDA•MODERATEAripiprazole 30 mg TabletsAjanta Pharma is recalling Aripiprazole 30 mg tablets due to a mix-up with Voriconazole 50 mg tablets.
FDA•MODERATEMedtronic O-arm O2 Imaging SystemMedtronic is recalling the O-arm O2 Imaging System due to a firmware anomaly that may cause image artifacts during clinical use.
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemHarmonyAIR A-Series surgical lights recalled: intensity buttons may detach.
2 products
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemSteris is recalling HarmonyAIR A-Series Surgical Lighting Systems due to a risk of paint delamination on the light heads.
FDA•CRITICALNara Organics Whole Milk Organic Infant FormulaNara Organics is recalling Whole Milk Organic Infant Formula over potential Clostridium botulinum contamination.
FDA•MODERATEDabur India: Multiple Made In India ProductsDabur India recalls 14 OTC topical products over CGMP deviations.
14 products
FDA•MODERATEChlorthalidone 25 mg TabletsChlorthalidone 25 mg tablets are being recalled due to failed dissolution specifications.
FDA•LOWFocalin XR 5 mg CapsulesSandoz is recalling Focalin XR 5 mg capsules due to missing or incorrect lot numbers and expiration dates on the product labels.
FDA•MODERATEAlyacen 7/7/7 TabletsGlenmark is recalling Alyacen 7/7/7 tablets due to out-of-specification results for total impurities.
FDA•MODERATEVasopressin 2 Units/2 mL SyringesIntegraDose is recalling Vasopressin 2 Units/2 mL syringes due to subpotency, which may cause the drug to be ineffective.
FDA•MODERATEPAI: Multiple Kerr Insta-char In An ProductsVistaPharm recalls Kerr Insta-Char activated charcoal (25g/50g) for failing OTC monograph requirements.
4 products
FDA•MODERATEMedline EBSI KitMedline recalls EBSI Kit (EBSI1534) due to cracked butyrate tubing and recalled MASTISOL adhesive.
42 products
FDA•CRITICALImpella Heart Pump Software RecallAbbott's Impella heart pumps may fail to restart after certain operational faults, posing a serious health risk to patients.
2 products
FDA•CRITICALParacentesis KitArrow International recalls paracentesis kits due to supplier quality issues with included injectables, risking serious injury.
51 products
FDA•CRITICALAzuma Foods Tako Wasabi Seasoned OctopusAzuma Foods is recalling Tako Wasabi Seasoned Octopus due to undeclared fish.
FDA•MODERATEHalyard Pain PackAVID Medical recalls Halyard Pain Pack kits (AMPK48-01) over possible lack of sterilization.
4 products
FDA•MODERATEMOSAIQ Oncology Information SystemElekta is recalling the MOSAIQ Oncology Information System due to a software error that may prevent the loading of baseline shift plans.
FDA•MODERATEBoston Scientific Orca Air/Water and Suction ValvesBoston Scientific is recalling Orca single-use air/water and suction valves due to reports of the suction button sticking during use.
- Device RecallFDA•MODERATEMerlin Patient Care System Programmer Software
Abbott Medical is recalling Merlin PCS software for the Model 3330 programmer due to a potential failure to terminate pacing tests.
FDA•MODERATEBoston Scientific Clik X AnchorBoston Scientific is recalling the Clik X Anchor due to a potential lack of sterility assurance.
FDA•MODERATEBoston Scientific CSK ElectrodesBoston Scientific recalls CSK reusable electrodes over performance concerns.
4 products
FDA•LOWPrimidone 50 mg TabletsAmneal Pharmaceuticals is recalling Primidone 50 mg tablets due to potential cross-contamination with Acemetacin API.
FDA•MODERATEMinocycline Hydrochloride 115 mg TabletsAscend Laboratories is recalling Minocycline Hydrochloride 115 mg tablets due to failed dissolution specifications.
FDA•MODERATENeuro Nourish Dietary SupplementSensory Supplement is recalling Neuro Nourish dietary supplement due to premature lipid oxidation causing off odors and bitter taste.
3 products
FDA•MODERATEZep Alcohol Sanitizer SprayZep Inc. is recalling 55-gallon containers of Alcohol Sanitizer Spray due to potential microbial contamination.
FDA•MODERATEAdvance Aluminum Chloride Gel Hemostatic KitInter-Med is recalling Aluminum Chloride Gel kits due to an incorrect package insert that provides dangerous first aid instructions.
FDA•MODERATEDragonfly Thai Ginger PowderDragonfly Thai Ginger Powder is being recalled due to potential lead contamination.
FDA•MODERATEHintermann Series Talar ImplantDT MedTech is recalling the Hintermann Series Talar Implant due to a labeling error that may result in the wrong implant being used.
FDA•MODERATESiemens Dimension Tacrolimus Flex Reagent CartridgeSiemens is recalling Dimension Tacrolimus Flex reagent cartridges due to a potential positive bias in test results.
FDA•MODERATEPark St. Deli Macaroni & CheesePark St. Deli Macaroni & Cheese is recalled due to an undeclared soy lecithin allergen.
FDA•CRITICALBeekeeper's Naturals Saline Nasal SprayBeekeeper's Naturals recalls Saline Nasal Spray due to microbial contamination.
2 products
FDA•MODERATEMedartis APTUS Cannulated Compression ScrewsMedartis is recalling APTUS cannulated compression screws due to a manufacturing defect where the cannulation is not centered.
FDA•MODERATEEXENT AnalyserThe Binding Site is recalling the EXENT Analyser due to a software error that may cause inaccurate M-protein detection or measurements.
FDA•MODERATEBudesonide Inhalation SuspensionSun Pharmaceutical is recalling Budesonide Inhalation Suspension (1mg/2mL) due to the presence of foreign black or brown particles.
FDA•MODERATEBreckenridge Pharmaceutical: multiple capsulesBreckenridge recalls Duloxetine 30mg and 60mg capsules due to N-nitroso-duloxetine impurity above FDA limit.
2 products
FDA•MODERATENeoSpan SuperElastic Compression StapleIn2bones USA is recalling 10+ variants of NeoSpan compression staples due to missing MR Conditional safety labeling.
2 products
FDA•LOWWeikfield Custard Powder Kesar PistaWeikfield recalls Kesar Pista Custard Powder 300g over mislabeled ingredient (Pista vs. Pistachio).
FDA•CRITICALCareFusion 213: Multiple Chlorhexidine Gluconate SolutionsBD recalls ChloraPrep Clear and FREPP Clear applicators due to sterility seal breach risk.
4 products
FDA•MODERATECareFusion 213: Multiple Subsidiary Of Beckton SolutionsBD recalls ChloraPrep & PurPrep applicators due to lack of sterility assurance, posing infection risk.
10 products
FDA•LOWEpinephrine Injection 1mg/mLFresenius Kabi is recalling Epinephrine Injection 1mg/mL vials due to out-of-specification stability test results.
FDA•MODERATEMicromed SD LTM 64 PLUS EEG AmplifierMicromed is recalling SD LTM 64 PLUS EEG amplifiers due to a potential one-second temporal delay that may cause misinterpretation of results.
FDA•MODERATECGuard Prime Carotid Stent SystemInspireMD recalls CGuard Prime Carotid Stent System (model CND0830) due to deployment complications.
6 products
FDA•MODERATECORFLO Safety PEG KitAvanos recalls CORFLO Safety PEG Kit (model 30-4320) due to supplier-recalled lidocaine.
20 products
FDA•MODERATEMahurkar Elite PASS TraysMozarc Medical is recalling Mahurkar Elite PASS Trays because the Tegaderm CHG dressing is missing from the packaging.
2 products
FDA•MODERATEGE Allia IGS 3 Pulse Angiographic X-ray SystemGE recalls Allia IGS 3 Pulse X-ray systems over electrical shock risk to service personnel.
5 products
FDA•MODERATEBicarby DialysateFresenius Medical Care is recalling Bicarby Dialysate due to a luer-lock leak issue that poses a slip and fall hazard.
FDA•MODERATEPlum Solo Precision IV PumpICU Medical recalls Plum Solo IV Pump over soft limit alert failure.
3 products