FDA medical device recalls
Formal FDA enforcement reports for medical devices — implants, monitors, diagnostic tests, and hospital and home-use equipment.
2,600 recalls in the last 12 months, translated into plain English.
- 2025-12-10Get TestedClass IIHair Mineral Analysis
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIGut Microbiome Test XL
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIGut Microbiome Test Small
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIGut Microbiome Test Mega
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIGut Microbiome Test Medium
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIGut Microbiome Test Large
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFructose Intolerance Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIDHEA Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IICandida Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIBiological Age & Longevity Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIAkkermansia Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIAdrenal Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IICholesterol Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIContinuous Glucose Monitor (CGM)
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIAllergy Test IgE
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIVitamin D2 and D3 Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIOrganic Acids Profile Test Large
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IINAD Profile Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIMycotoxin Panel Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIGI Microbiome Profile XL
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIGI Microbiome Profile Small
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFood Sensitivity Test Small
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFood Sensitivity Test Medium
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFood Sensitivity Test Large
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFood Allergy Panel Test (IgE)
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIEnvironmental Pollutants Profile Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IISperm Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIVitamin D-Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIVaginal PH Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIUrinary Tract Infection Test
Distribution without premarket approval/clearance.
Get notified about new FDA Device recalls
Free weekly digest of new federal recalls, in plain English.