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.

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DateProductReasonClassFirm
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
Nov 2, 2025 MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software... A software timing and processor communication issue in MiniMed" 780G software version 6.60 may tr... Class II Medtronic MiniMed, Inc.
Oct 31, 2025 IntelliVue MP70. Product Number: M8007A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 31, 2025 IntelliVue Patient Monitor MX450. Product Number: 866062. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 Olympus OER-Mini Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended... Class II Aizu Olympus Co., Ltd.
Oct 31, 2025 IntelliVue Patient Monitor MX750. Product Number: 866471. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX550. Product Number: 866066. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 Olympus OER-Pro Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended... Class II Aizu Olympus Co., Ltd.
Oct 31, 2025 IntelliVue Multi-Measurement Module X3. Product Number: 867030. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc

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.