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 Women 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 Diabetes Test (ketones & glucose) 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 Kidney 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 Liver 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 & Food 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 Allergy 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 Allergy 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 Estrogen & Progesterone 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 Intolerance 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 Intolerance 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 Intolerance 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 Heavy Metals 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 Iodine 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 Iron Deficiency Test (ferritin) 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 Melatonin 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 Pet Allergy 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 Pollen Allergy 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 Serotonin 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 2 in 1 Trichomonas / Gardnerella 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 3 in 1 STI 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 8 in 1 STI Test Kit 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 Welch Allyn INF BAG, Thigh 1-Tube Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in… Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Ohio and Utah named
- Medical device recall Ivenix Infusion System (IIS), Large Volume Pump Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall IntelliVue MP2 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MP5 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MP20 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MP30 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MP40 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MP50 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MP60 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MP70 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MP80 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue MP90 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Multi Measurement Server X2 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Multi-Measurement Module X3 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX100 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX400 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX450 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX500 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX550 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX600 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX700 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX750 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX800 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX850 Potential issue where the IntelliVue monitors did not alarm. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may… Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Louisiana, Maryland, New Jersey, New Mexico, Nevada, New York, Ohio, Tennessee, Texas and Washington named
- Medical device recall Olympus OER-Elite Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained… Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus OER-Pro Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained… 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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