Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall Am I Pregnant? One Step HCG Pregnancy Test Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall To Life hCG Pregnancy Urine Test Strips Format Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall PrestiBio BREAST MILK ALCOHOL TEST STRIP Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall PrestiBio Ovulation Strips Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall PrestiBio Ovulation and Pregnancy Strips Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall PrestiBio Pregnancy Strips Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall PrestiBio Rapid Detection Pregnancy Test Midstream Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall PrestiBio KETONE TEST STRIPS Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall PrestiBio URINALASYS TEST STRIP 10 PARAMETERS Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall DiagnosUS One Step LH Ovulation Test Strip Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall DiagnosUS¿ One Step FSH Menopausal Test (Strip) Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall Lem Fertility hCG Pregnancy Urine Test Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall Lem Fertility LH Ovulation Test (Strip) Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall DiagnosUS hCG Pregnancy Urine Test Strip Format Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall DiagnosUS hCG Pregnancy Urine Test Cassette Format Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall DiagnosUS Pregnancy Test Midstream Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall DiagnosUS Ovulation Predictor Midstream Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall OMTMO One Step Ovulation (LH) Test Strips Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall Astral 100 and Astral 150 ventilators If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedNov 1, 2023ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8713051U, Infusomat Large Volume Pump, Wireless Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall SynCardia 50cc TAH-t, Clinical Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusCompletedWhereArizona, California, Florida, Illinois, Indiana, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall TruDi Navigation System When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report30 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas and Wisconsin
- Medical device recall Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures… Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3 GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1 GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes The complaint involved the absence of a component called “ASM Filter-Pro ABG SYR CAP” from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Centricity Universal Viewer Workflow Manager, Image processing radiological system When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Maine, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee and Texas named
- Medical device recall Universal Viewer Workflow Manager, Image processing radiological system When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Maine, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee and Texas named
- Medical device recall Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 1, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monoject” 6 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 1, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monoject” 12 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 1, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monoject 20 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 1, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monoject” 35 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 1, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monoject” 60 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 1, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, New Jersey, Ohio, Oregon, South Carolina and Texas
- Medical device recall Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, New Jersey, Ohio, Oregon, South Carolina and Texas
- Medical device recall Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, New Jersey, Ohio, Oregon, South Carolina and Texas
- Medical device recall SOZO Bilateral Arm L-Dex Software Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Omega Medical Imaging Elevating Monitor Suspension An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6 The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home… May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass 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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