Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190 Packaging Incomplete Seal. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN:… Packaging Incomplete Seal. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY A number of MDNC-3421 displays were shipped while not being DICOM-compliant. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereWisconsin
- Medical device recall Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, California, Guam, Iowa, Illinois, Michigan, Missouri, North Carolina, Nebraska, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas and Washington named
- Medical device recall S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative… Medline Industries, Inc. Class IIIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 3, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Illinois, Mississippi and Ohio named
- Medical device recall VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample… A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh Due to unqualified “design verification” batteries being shipped to customers. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 3, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Iowa, Illinois, Minnesota, Missouri, North Carolina, North Dakota, Ohio, Texas and Utah named
- Medical device recall CV Basin Set Pack Sternum saw blades within procedure packs are not sterile. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereMichigan, Oklahoma and Texas
- Medical device recall Open Heart Pack Sternum saw blades within procedure packs are not sterile. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereMichigan, Oklahoma and Texas
- Medical device recall Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure… Sternum saw blades within procedure packs are not sterile. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereMichigan, Oklahoma and Texas
- Medical device recall Slush + Warmer Disc Drape Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the… incorrect device is contained in the package. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining… The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medical device recall ARTIS Icono biplane Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend” Tracheostomy Tube (model… Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend” Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172,… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia and Washington named
- Medical device recall ENROUTE Transcarotid Stent System Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement Report43 statesnamed in where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ConMed 50L abdominal insufflator An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida and Ohio named
- Medical device recall Steris CO2MPACT Endoscopic Insufflator system An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida and Ohio named
- Medical device recall OT1000 Series Orthopedic Surgical Tables On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Infusion Pump Battery performance issues related to prolonged storage. Class IIFDA’s classMar 3, 2021in FDA’s Enforcement Report52 statesnamed in where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereAlaska, 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, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall BD Hypodermic Syringe 10 ml, eccentric tip The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423) There is the potential of a bent or disconnected needle in one of the components of the convenience kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401) There is the potential of a bent or disconnected needle in one of the components of the convenience kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994) There is the potential of a bent or disconnected needle in one of the components of the convenience kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) There is the potential of a bent or disconnected needle in one of the components of the convenience kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) There is the potential of a bent or disconnected needle in one of the components of the convenience kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 -… Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of… Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of… Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT… Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of… Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Gambro Cartridge Blood Set Prime Line complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 24, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Gambro Cartridge Single Needle Conversion Kit complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 24, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Gambro Cartridge Blood Transport System for Hemodialysis Blood Set complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 24, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Gambro Cartridge Blood Transport System for Hemodialysis Blood Set complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 24, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 24, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 24, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for… The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Maryland, Minnesota, North Carolina, North Dakota, Nebraska, New York, Pennsylvania and Virginia named
- Medical device recall Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedFeb 24, 2021ClassClass 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, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedFeb 24, 2021ClassClass 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, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole… Distributed COVID test kits without emergency use authorization. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the… Potential for false negative diagnosis of gastroparesis. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Kansas, Michigan, North Carolina and New York named
- Medical device recall System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the… Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES. GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the… Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder… Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kentucky, Michigan, Minnesota, Mississippi, Ohio, Tennessee, Utah and Wisconsin named
- Medical device recall LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA Observations of potential false positive results in the specified lots. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Pennsylvania and South Dakota
- Medical device recall IOLMaster 700 When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient… Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement Report39 statesnamed in where it went PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall SenTec Digital Monitor Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia, Illinois, Massachusetts, New Jersey and Pennsylvania
- Medical device recall EMBLEM S-ICD Electrical overstress may lead to device malfunction. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 17, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 17, 2021ClassClass IStatusTerminatedWhereNo state named
- Medical device recall EMBLEM MRI S-ICD Electrical overstress may lead to device malfunction. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 17, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 17, 2021ClassClass IStatusTerminatedWhereNo 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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