Hawaii recalls
3,429 federal recalls affecting Hawaii in the last 12 months - 67 Hawaii-specific plus 3,362 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-12-10FDA-DeviceGet TestedClass IINationwidePregnancy Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideParasite Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideOvulation Test (5 tests)
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideMycoplasma test, IgG and IgM
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideMPOX Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideMenopause (FSH) 2 Tests
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideLyme Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideIron Deficiency Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideHPV Antigen Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideHerpes (HSV-1 & HSV-2) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideH pylori (Peptic ulcer) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideGonorrhea test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideFemale Fertility Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideFecal Occult Blood Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideEpstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideDrug Test Small (4 substances)
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideIllegally Marketed
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideDiabetes HbA1c Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideD-Dimer Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideChlamydia Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideCandida Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideBlood Type Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideAlcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceMedtronicClass IINationwideAurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- 2025-12-10FDA-DeviceEnterixClass IINationwideInSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
- 2025-12-10FDA-DeviceFresenius KabiClass INationwideIVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- 2025-12-10FDA-FoodPrime Food ProcessingClass IILava Bun with Salted Egg Yolk orange packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Products do not declare milk in the Contains statement or the ingredient statement.
- 2025-12-10FDA-FoodPrime Food ProcessingClass IILava Bun with Green Tea Flavor bright lime green packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Products do not declare milk in the Contains statement or the ingredient statement.
- 2025-12-10FDA-FoodAmerican NutsClass IDry Roasted Baking Macadamia Nuts, Unsalted Halves Ideal for Baking, Cooking, Salads or Ice Cream; NET WT 20 OZ (1 LB 4 OZ) 567g UPC: 8 60011 44301 8
Potential Salmonella contamination.
- 2025-12-10FDA-FoodMeadowgoldClass IIMeadow Gold Hawaii's Dairy Fat Free Chocolate Milk, Grade A Pasteurized Homogenized Vitamin A&D, half-pint carton. Product is perishable keep refrigerated. UPC 8 50019 06410 0. Ingredients: Nonfat Milk, Sugar Cane, Cocoa (processed with Alkali), Corn Starch, Carrageenan, Salt, Natural Flavor, Vitamin A Palmitate, Vitamin D3. Distributed By: Meadow Gold Dairies, Hilo, HI. Plant #06-2374
Half-pint chocolate fat free milk is recalled due to potential quality control issues.
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