Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Sperm Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Syphilis Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Thyroid TSH Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Trichomonas Vaginalis test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Urinary Tract Infection Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vaginal PH Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vitamin D-Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sperm Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Environmental Pollutants Profile Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Food Allergy Panel Test (IgE) Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Food Sensitivity Test Large Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Food Sensitivity Test Medium Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Food Sensitivity Test Small Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GI Microbiome Profile Small Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GI Microbiome Profile XL Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mycotoxin Panel Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NAD Profile Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Organic Acids Profile Test Large Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vitamin D2 and D3 Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allergy Test IgE Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Continuous Glucose Monitor (CGM) Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cholesterol Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Adrenal Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Akkermansia Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biological Age & Longevity Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Candida Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DHEA Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fructose Intolerance Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gut Microbiome Test Large Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gut Microbiome Test Medium Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gut Microbiome Test Mega Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gut Microbiome Test Small Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gut Microbiome Test XL Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hair Mineral Analysis Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IBS Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intestinal Worms Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Lactose Intolerance Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leaky Gut Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Men s Hormone Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Neurotransmitters Basic Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Neurotransmitters Plus Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Neurotransmitters XL Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Organic acids Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Parasite Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Peptic Ulcer Test (H, pylori) Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PSA Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIBO Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sorbitol Intolerance Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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