Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams There is a potential for the gel packets to have leaks in the packet seal. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Iowa, Illinois, Ohio, Tennessee and Virginia
- Medical device recall Syngo.Via VB20A Functionality in the report sections “Findings Information” and “Summary of Measured Findings” not functioning properly. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EasyTouch (ET) Insulin Syringe 29G 1ml ¿” (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN… The retail shelf cartons may be labeled with an incorrect lot number. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 16, 2018ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿” (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100… The retail shelf cartons may be labeled with an incorrect lot number. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 16, 2018ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall NvisionVLE¿ Low-Profile Optical Probe Distal tips of the probes may detach from the probe shaft during use. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Illinois, Massachusetts, New Jersey, New Mexico, New York and Texas named
- Medical device recall Ondamed Biofeedback Device The firm was marketing the Ondamed System in the US without marketing clearance. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Jasper Vektor, Class II Correction Appliance The firm has received 106 complaints of the device breaking in the patient’s mouth. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Hawaii, Idaho, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase) Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MicroVue BAP EIA There is a possibility of low volume and/or leaking standard bottles. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Missouri, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System Module may freeze without generating user warning. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereIllinois and New York
- Medical device recall Syva¿ EMIT¿ II Plus 6-Acetylmorphine Incorrect calibrator level listed in qualitative calibration steps Class IIIFDA’s classMay 16, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 16, 2018ClassClass IIIStatusTerminatedWhereFlorida, Kansas, Kentucky, Massachusetts, Maine, New Hampshire, Pennsylvania, Texas and Utah
- Medical device recall Syva¿ EMIT¿ II Plus 6-Acetyl morphine Incorrect calibrator level listed in qualitative calibration steps Class IIIFDA’s classMay 16, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 16, 2018ClassClass IIIStatusTerminatedWhereFlorida, Kansas, Kentucky, Massachusetts, Maine, New Hampshire, Pennsylvania, Texas and Utah
- Medical device recall Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP Products were packaged with incorrect labeling, Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray… To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Emotion to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of… to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SOMATOM Emotion Duo To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Beijing Syntech Laser Diode Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beijing Syntech Laser Trixel C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beijing Syntech Laser UL C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beijing Syntech Laser Nice Station Light Based Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beijing Syntech Laser UL Station surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for… Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 9, 2018ClassClass IIStatusOngoingWhereNo state named
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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