Browse Device Recalls
2,817 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,817 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,817 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 3, 2025 | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion Sys... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Melatonin Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Women s Hormone Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Fecal Occult Blood Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Epstein-Barr Virus (EBV VCA & EBNA IgG) Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Neurotransmitters Basic | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | H pylori (Peptic ulcer) Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Men s Hormone Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Sensitivity Test Medium | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Ovulation Test (5 tests) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy & Food Intolerance Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Pregnancy Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Liver Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Diabetes Test (ketones & glucose) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Iron Deficiency Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Herpes (HSV-1 & HSV-2) Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Thyroid TSH Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Iron Deficiency Test (ferritin) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Cholesterol Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Gonorrhea test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Chlamydia Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Gut Microbiome Test Large | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Hair Mineral Analysis | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Organic acids Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Drug Test Small (4 substances) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Lyme Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Biological Age & Longevity Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | 3 in 1 STI Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Blood Type Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Menopause (FSH) 2 Tests | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | 2 in 1 Trichomonas / Gardnerella Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Kidney Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Leaky Gut Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Vitamin D2 and D3 Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | NAD Profile Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Intolerance Test Large | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Allergy Panel Test (IgE) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PT... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Gut Microbiome Test Mega | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Female Fertility Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Serotonin Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | DHEA Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Sperm Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Parasite Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti ... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | GI Microbiome Profile Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | MPOX Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Iodine Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Syphilis Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Candida Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.