Massachusetts recalls
3562 federal recalls on file affecting Massachusetts - 486 Massachusetts-specific plus 3076 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideUrinary Tract Infection Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideTrichomonas Vaginalis test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideThyroid TSH Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideSyphilis Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideSperm Test
Distribution without premarket approval/clearance.
- 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.
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