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 Flo-Thru Intraluminal Shunt There is a potential for foreign matter. Class IIFDA’s classMay 11, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 11, 2022ClassClass IIStatusTerminatedWhereAlabama, California, Kentucky, New York, Oregon, Pennsylvania and Texas
- Medical device recall Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of… Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of… Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination… Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of… Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of… Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of… Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Non-Sterile Double Ended Trial Kit, Small Footprint Product labeled incorrectly. Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 11, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Indiana, Kentucky, North Carolina, New Jersey, Texas and Virginia named
- Medical device recall Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 11, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Indiana, Kentucky, North Carolina, New Jersey, Texas and Virginia named
- Medical device recall Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818) During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 11, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Indiana, Kentucky, North Carolina, New Jersey, Texas and Virginia named
- Medical device recall VELYS Robotic-Assisted Solution Base Product No.: 451570100 System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to… Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Restrata, Part Number RWM1-2X2 Misprinted expiration date on the shelf-box Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon) Kits contained recalled acetaminophen. Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRAY RING COVER Potential breach in the sterility barrier for tray ring covers. Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 11, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Ultrasonic Gastrovideoscope, GF-UC140P-AL5 GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall K-Wire, 1.35 mm x 170 mm Products do not meet length and diameter specifications. Class IIFDA’s classMay 11, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 11, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Iowa, Louisiana, Missouri, New York, Ohio, Oregon, Pennsylvania and Tennessee named
- Medical device recall Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall PrisMax System This correction is due to software anomalies occurring during use. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PrisMax System This correction is due to software anomalies occurring during use. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PrisMax System This correction is due to software anomalies occurring during use. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall syngo.via RT Image Suite upgraded to VB60 running on syngo.via Upgraded software version makes an automatic change in laser configuration settings for “markerless workflow” which may lead to the wrong laser offset… Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Illinois, Indiana, Kentucky, Maryland, Missouri, North Dakota, New Hampshire, New York, Ohio, Oregon, Pennsylvania, South Dakota, Texas and Virginia named
- Medical device recall syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Upgraded software version makes an automatic change in laser configuration settings for “markerless workflow” which may lead to the wrong laser offset… Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Illinois, Indiana, Kentucky, Maryland, Missouri, North Dakota, New Hampshire, New York, Ohio, Oregon, Pennsylvania, South Dakota, Texas and Virginia named
- Medical device recall syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Upgraded software version makes an automatic change in laser configuration settings for “markerless workflow” which may lead to the wrong laser offset… Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Illinois, Indiana, Kentucky, Maryland, Missouri, North Dakota, New Hampshire, New York, Ohio, Oregon, Pennsylvania, South Dakota, Texas and Virginia named
- Medical device recall syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Upgraded software version makes an automatic change in laser configuration settings for “markerless workflow” which may lead to the wrong laser offset… Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Illinois, Indiana, Kentucky, Maryland, Missouri, North Dakota, New Hampshire, New York, Ohio, Oregon, Pennsylvania, South Dakota, Texas and Virginia named
- Medical device recall MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with… There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e… Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall da Vinici X da Vinci Xi Sureform 45 As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within… Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMay 4, 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, 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 named
- Medical device recall NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following… Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets… Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Maryland, Michigan, Missouri, New York, Ohio and Virginia named
- Medical device recall TearCare version 1.0 SmartHubs Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance… Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, West Virginia and Wyoming named
- Medical device recall SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101 Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SpaceOAR Vue System, UPN SV-1010 and SV-2101 Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Convenience kits containing regard IV Start Kits A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall Convenience kits containing regard IV Start Kits A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall ZEISS miLOOP Lens Fragmentation Device High friction of the slider can cause the device to stick, or not move as intended. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement Report32 statesnamed in where it went PublishedMay 4, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001 Potential for patient data mismatch when using browser “back” button to navigate between patients when using the diabetes management software. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Texas and Wisconsin named
- Medical device recall Acuson 9vE4 Transducer Transducers (component of ultrasound system) may exceed recommended thermal index limits Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, New York, Ohio, Pennsylvania, South Carolina, Texas and Washington named
- Medical device recall Smart Toe II Intramedullary Arthrodesis Implant The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing “Indicated for patients with Nickel… Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 Software issue resulting in temporary loss of central monitoring functionality. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Louisiana, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall WAVES WCM Kidney Cassette Module There is a potential for the WCM cassette pump head leaking solution. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Updated and revised user instructions issued 7/14/22. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IMMULITE 2000 Systems HCG [200 Tests, material number 10381206 Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors. Class IIFDA’s classMay 4, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 4, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Indiana, Minnesota, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia Class IIFDA’s classMay 4, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereGeorgia and Ohio
- Medical device recall Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia Class IIFDA’s classMay 4, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 4, 2022ClassClass IIStatusTerminatedWhereGeorgia and Ohio
- Medical device recall Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617,… Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 27, 2022ClassClass IStatusOngoingWhereNationwide, and 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276) Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 27, 2022ClassClass IStatusOngoingWhereNationwide, and 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 27, 2022ClassClass IStatusOngoingWhereNationwide, and 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Harmony Delivery Catheter System There is potential for the capsule bond to break during the procedure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IStatusOngoingWhereNationwide
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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