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 IIPet Allergy Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIMelatonin Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIIron Deficiency Test (ferritin)
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIIodine Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIHeavy Metals Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFood Intolerance Test Small
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFood Intolerance Test Medium
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFood Intolerance Test Large
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIEstrogen & Progesterone Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIAllergy test Small
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIAllergy test Small
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIAllergy & Food Intolerance Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IILiver Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIKidney Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIDiabetes Test (ketones & glucose)
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIWomen s Hormone Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IISorbitol Intolerance Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IISIBO Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIPSA Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIPeptic Ulcer Test (H, pylori)
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIParasite Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIOrganic acids Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IINeurotransmitters XL
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IINeurotransmitters Plus
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IINeurotransmitters Basic
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIMen s Hormone Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IILeaky Gut Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IILactose Intolerance Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIIntestinal Worms Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIIBS Test
Distribution without premarket approval/clearance.
Get notified about new FDA Device recalls
Free weekly digest of new federal recalls, in plain English.