Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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 6, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Gentell Honey Hydrogel 2”x2” Saturated Gauze- A hydrating wound dressing containing hydrogel and honey During an FDA audit, it was discovered that the product was not properly registered with FDA. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gentell Honey Hydrogel 4”x4” Saturated Gauze- A hydrating wound dressing containing hydrogel and honey During an FDA audit, it was discovered that the product was not properly registered with FDA. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gentell Honey Hydrogel 4”x8” Saturated Gauze- A hydrating wound dressing containing hydrogel and honey During an FDA audit, it was discovered that the product was not properly registered with FDA. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gentell Honey Hydrogel Hydrogel 4oz During an FDA audit, it was discovered that the product was not properly registered with FDA. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall REF: AH7117 111” 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall REF: B30211, 37” There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall REF: B90240-50, 96” There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall REF: B9900-287, 82” There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall REF: MC330424, 145” There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall REF: Z2560, 100” 10 Drop Admin Set w/Hand Pump, 2 Clave”, Rotating Luer, 1 Pressure Infusion There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall REF: Z2812, 121” 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext,… There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall REF: Z2850, 112” There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall REF: Z3239, 126” 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R,… There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall REF: Z3806, 131” There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Philips Brilliance iCT Computed Tomography X-Ray System The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportIowathe one state its words name PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereIowa
- Medical device recall Philips Brilliance iCT SP Computed Tomography X-Ray System The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportIowathe one state its words name PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereIowa
- Medical device recall Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportIowathe one state its words name PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereIowa
- Medical device recall WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left One lot of INBONE Tibial Trays is missing the plasma coating. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spy-Phi Drape (HH2000) Sterile drapes packaged in an unsealed pouch. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only) Sterile drapes packaged in an unsealed pouch. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall The Cogent Hemodynamic Monitoring System Firm identified software issues which leads to the patient ID and patient information not being stored in the system. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Illinois, Maryland, North Carolina, Nebraska, New York, Texas, Vermont, Washington and Wisconsin named
- Medical device recall Lunar iDXA bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Langston Dual Lumen Catheter 6F The inner lumen of the Langston catheter may separate from the hub during pressure injection. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereAlabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia and Wisconsin
- Medical device recall PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement Report33 statesnamed in where it went PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical… To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250) The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 6, 2020ClassClass IIStatusCompletedWhereNationwide, and Arizona, California, Florida, Iowa, Illinois, Louisiana, Mississippi, New York, Texas and Utah named
- Medical device recall Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional… No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia and Wisconsin named
- Medical device recall Zimmer Tourniquet Cuff 30” (Blue), PLC Dual Port, Single Bladder Tourniquet cuffs are potentially mislabeled. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, New York, South Carolina, Texas and Utah named
- Medical device recall ViewRay System Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Massachusetts, Michigan, Missouri, New York and Wisconsin
- Medical device recall iLab Polaris Multi-Modality Guidance System Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2020ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Obalon Balloon System with During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 6, 2020ClassClass IIStatusCompletedWhereNationwide, and Connecticut, Florida, Georgia, Louisiana, New Jersey, New York, Oregon, Tennessee, Texas and Virginia named
- Medical device recall Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Maine, Rhode Island, Texas and Wisconsin named
- Medical device recall Neptune E-SEP 165mm Blade Electrode Due to a distribution error, product from the affected lot was shipped expired. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a… Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Michigan and Virginia named
- Medical device recall Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion… When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereFlorida, Idaho, Illinois, Indiana, Massachusetts and Ohio
- Medical device recall Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI… Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables… Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM… Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF… Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA… Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP… Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL… Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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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