Device Recall
FDA•MODERATE
STAAR ICL Calculation Software
Staar Surgical is recalling Version 8.00 of its ICL Calculation Software due to a coding error affecting toric lens orientation diagrams.
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FDA•CRITICALTaro CakesE & S Grocery & Bakery is recalling Taro Cakes due to an undeclared egg allergen.
FDA•MODERATEPhilips MultiDiagnost Eleva Hand SwitchPhilips recalls MultiDiagnost Eleva systems over hand switch that may not release, risking unintended radiation.
3 products
FDA•MODERATENutrisystem Chocolate CheesecakeNutrisystem is recalling Chocolate Cheesecake 2 oz packages due to an undeclared soy allergen.
FDA•CRITICALAl Yaman Halawa Extra PistachioAl Yaman Halawa Extra Pistachio 907g jars recalled over possible Salmonella contamination.
FDA•MODERATEGreat Value Hawaiian Roll 4pkGreat Value Hawaiian Roll 4pk recalled over oily substance on food-contact packaging; product never reached store shelves.
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•MODERATEMID DOLCIARIA SRL: 2 Via Casalini BelpassosMID DOLCIARIA recalls Cannoli Siciliani and Crunchy Cannoli Gluten Free over unapproved colors E140/E141.
2 products
FDA•MODERATETrigen Proximal Straight Humeral NailSmith & Nephew is recalling the Trigen Proximal Straight Humeral Nail due to a manufacturing error that may cause surgical delays or revision.
FDA•CRITICALFirst Street Dark Chocolate RaisinsFirst Street Dark Chocolate Raisins are recalled due to undeclared peanuts, which pose a risk to consumers with peanut allergies.
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•MODERATEPepperoni Rolls 5 ozPepperoni Rolls recalled for undeclared milk allergen and improper refrigeration; 5 oz packages.
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•MODERATENiacin Extended-Release Tablets 1,000 mgGolden State Medical Supply is recalling Niacin Extended-Release Tablets, 1,000 mg, due to failure to meet dissolution specifications.
2 products
FDA•MODERATEFresh Roast Systems ColorTrack InstrumentFresh Roast Systems is recalling the ColorTrack instrument (Model BENCH R-100) due to a potential laser safety hazard.
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•MODERATEBicarby DialysateFresenius Medical Care is recalling Bicarby Dialysate due to a GTIN labeling error that may result in the use of an incorrect potassium solution.
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•CRITICALClover Hill Dairy LLP: 18 productsClover Hill Dairy recalls multiple soft cheeses (Ricotta, Cuajada, Cheddar) over Listeria risk. Discard or return.
18 products
FDA•LOWPasteurized Donor Human Milk 3 ozMothers' Milk Bank of Louisiana recalls 3 oz Pasteurized Donor Human Milk over potential physical contamination.
FDA•CRITICALBeekeeper's Naturals Saline Nasal SprayBeekeeper's Naturals recalls Saline Nasal Spray due to microbial contamination.
2 products
FDA•LOWEstrella Passion Fruit DrinkEstrella is recalling its Passion Fruit Drink due to undeclared FD&C Red 40.
FDA•MODERATEFarm Rich Pizza Cheese CrunchersFarm Rich Pizza Cheese Crunchers recalled over possible metal pieces.