Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, 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.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereMaryland and Pennsylvania
- Medical device recall Virus Counter Platform with The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Matrix Clinical Solution At-Home COVID-19 Test Due to COVID-19 Test not being authorized for home sample collection. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement Report25 statesnamed in where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and West Virginia
- Medical device recall Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow Product is mislabeled as self-righting Luer slip tip caps, yellow. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Illinois, Indiana, Missouri, Pennsylvania, Texas and Virginia named
- Medical device recall Cardiovascular Procedure Kit Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California and Indiana named
- Medical device recall Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site A kit component, the PDI Prevantics Swab, was recalled. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportMissourithe one state its words name PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall therascreen KRAS RGQ PCR Kit False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement Report17 statesnamed in where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereArizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Minnesota, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and West Virginia
- Medical device recall therascreen KRAS RGQ PCR Kit False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement Report17 statesnamed in where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereArizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Minnesota, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and West Virginia
- Medical device recall Inactivated macrolide and quinolone-resistant Mycoplasma genitalium QC process was not adequate for the specification range. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Inactivated macrolide-resistant Mycoplasma genitalium The QC process was not adequate for the specification range. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and Nevada and Vermont named
- Medical device recall Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F Devices were manufactured with a “First Use Date” preprogrammed in the EEPROM which disables the use of the single-use device. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD Devices were manufactured with a “First Use Date” preprogrammed in the EEPROM which disables the use of the single-use device. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4.0mm x 10mm Cannulated Screw, Short Thread Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedApr 27, 2022ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall 4.0mm x 12mm Cannulated Screw, Short Thread Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedApr 27, 2022ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box) Faceplate may become detached from the probe body. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Michigan, Oklahoma and Virginia named
- Medical device recall Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001 As a result of Medtronic’s integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up… Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Sight OLO device is a computer vision based platform for blood analysis In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Merlin PCS 3650 programmer Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide, 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Merlin 2 PCS MER3700 programmer Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide, 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Artis zee floor If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis zee ceiling If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis zee multi-purpose If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis zee biplane If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis zee floor MN If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis zee biplane MN If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis zeego, Model Number 10280959 If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis Q floor If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis Q ceiling If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis Q biplane If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis Q zeego If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis Q.zen floor If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis Q.zen ceiling If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis Q.zen biplane If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ORAcollect Dx Evaporation of stabilizing liquid reducing shelf life. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall ORAcollect RNA: ORE-100 Evaporation of stabilizing liquid reducing shelf life. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall GE Healthcare MR Systems, Magnetic Resonance imaging (MRI) During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall Beckman Coulter IRISpec CA/CB/CC control IRISpec CA failures for glucose. Class IIIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 27, 2022ClassClass IIIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM) Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM) Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM) Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gallant DR Implantable Cardioverter Defibrillator Bluetooth malfunction impacting Gallant devices post-implant. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida and Kentucky named
- Medical device recall Gallant VR Implantable Cardioverter Defibrillator Bluetooth malfunction impacting Gallant devices post-implant. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida and Kentucky named
- Medical device recall Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q Bluetooth malfunction impacting Gallant devices post-implant. Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 27, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida and Kentucky named
- Medical device recall Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iTotal Identity Posterior Stabilised (PS) Knee Replacement System Incorrect tibial base plate implant packaged in kit Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportMississippithe one state its words name PublishedApr 20, 2022ClassClass IIStatusCompletedWhereMississippi
- Medical device recall LIPOSORBER System Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement Report34 statesnamed in where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
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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