Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Nov 3, 2025 | Diabetes HbA1c Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | D-Dimer Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Intestinal Worms Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | SIBO Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Trichomonas Vaginalis test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Fructose Intolerance Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Heavy Metals Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Peptic Ulcer Test (H, pylori) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Sensitivity Test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Mycotoxin Panel Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbi... | Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious... | Class I | Fresenius Kabi USA, LLC |
| Nov 3, 2025 | Food Sensitivity Test Large | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image proces... | GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.... | Class II | GE Healthcare GmbH |
| Nov 3, 2025 | Food Intolerance Test Medium | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Akkermansia Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | 8 in 1 STI Test Kit | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Gut Microbiome Test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | PSA Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Lactose Intolerance Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Urinary Tract Infection Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System M... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Pet Allergy Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Gut Microbiome Test XL | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Alcohol (ALC) Test Saliva | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a chec... | Class II | Fresenius Kabi USA, LLC |
| Nov 3, 2025 | Pollen Allergy Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Neurotransmitters Plus | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Adrenal 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 | Mycoplasma test, IgG and IgM | 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 | HPV Antigen Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Illegally Marketed | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | GI Microbiome Profile XL | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy Test IgE | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Organic Acids Profile Test Large | 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 |
| Nov 3, 2025 | Vitamin D-Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Intolerance Test Small | 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.