Browse Device Recalls

38,509 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,509 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 38,509 FDA device recalls.

DateProductReasonClassFirm
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
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

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.