Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OmniDiagnost Eleva System codes 708028 708027 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Poly G Integris H5000, System code 72246 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UroDiagnost Eleva, system code 708033 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Allura CV20, system code 722031 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardio Vascular-Allura Centron, system code 722400 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q Biplane A software issue could potentially cause the stand and table movements to be blocked. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q.zen Biplane A software issue could potentially cause the stand and table movements to be blocked. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee Biplane A software issue could potentially cause the stand and table movements to be blocked. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water… The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HeartStart MRx Monitor/Defibrillators with Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after… Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system. The Ysio system may process incorrect internal values for the position of its ceiling tube stand. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, District of Columbia, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia and Wisconsin named
- Medical device recall AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage:… Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida and Virginia named
- Medical device recall D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI… The items identified for recall are labeled as sterile. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI… The items identified for recall are labeled as sterile. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be… The items identified for recall are labeled as sterile. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be… The items identified for recall are labeled as sterile. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LEGION PS High Flex XLPE size 5-6 9mm Articular Insert LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Louisiana, Michigan, North Carolina, New Mexico, Oregon, Pennsylvania, Puerto Rico, Tennessee and Texas
- Medical device recall Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE,… Potential diff. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE,… Potential diff. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle… Screws provided in the device package are 6 mm longer than intended. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereMassachusetts, Minnesota, North Dakota, Ohio, South Dakota and Tennessee
- Medical device recall Boston Scientific, LATITUDE Programming System Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Missouri, North Carolina and Tennessee named
- Medical device recall Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Missouri, North Carolina and Tennessee named
- Medical device recall IMMULITE 1000 Systems E2 Estradiol Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to… Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall IMMULITE 2000 Systems E2 Estradiol Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to… Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Custom procedure trays containing medical components needed to facilitate patient procedures and to perform… The medical procedure trays contain one or more recalled surgical gowns. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Custom procedure trays containing medical components needed to facilitate patient procedures and to perform… The medical procedure trays contain one or more recalled surgical gowns. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Custom procedure trays containing medical components needed to facilitate patient procedures and to perform… The medical procedure trays contain one or more recalled surgical gowns. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Custom procedure trays containing medical components needed to facilitate patient procedures and to perform… The medical procedure trays contain one or more recalled surgical gowns. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Custom procedure trays containing medical components needed to facilitate patient procedures and to perform… The medical procedure trays contain one or more recalled surgical gowns. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Custom procedure trays containing medical components needed to facilitate patient procedures and to perform… The medical procedure trays contain one or more recalled surgical gowns. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Custom procedure trays containing medical components needed to facilitate patient procedures and to perform… The medical procedure trays contain one or more recalled surgical gowns. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Custom procedure trays containing medical components needed to facilitate patient procedures and to perform… The medical procedure trays contain one or more recalled surgical gowns. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Custom procedure trays containing medical components needed to facilitate patient procedures and to perform… The medical procedure trays contain one or more recalled surgical gowns. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereArizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Medtronic CareLink 2090 Programmer Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of… Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 25, 2020ClassClass IIStatusOngoingWhereNationwide, and American Samoa, Georgia, Guam, Northern Mariana Islands and Puerto Rico named
- Medical device recall Medtronic CareLink Encore 29901 Programmer Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of… Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 25, 2020ClassClass IIStatusOngoingWhereNationwide, and American Samoa, Georgia, Guam, Northern Mariana Islands and Puerto Rico named
- Medical device recall OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of… Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Texas and Washington named
- Medical device recall HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in… Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 18, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 18, 2020ClassClass IStatusOngoingWhereNo state named
- Medical device recall HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic… Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 18, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 18, 2020ClassClass IStatusOngoingWhereNo state named
- Medical device recall BodyGuard Microset When using a specific tubing set with infusion pump system, may result in under deliver of fluids. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 18, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 18, 2020ClassClass IStatusTerminatedWhereCalifornia, Ohio, Pennsylvania and Texas
- Medical device recall Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient’s mitral or… Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 18, 2020ClassClass IIStatusOngoingWhereNationwide, and Kansas and Ohio named
- Medical device recall Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient’s mitral or tricuspid valve… Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 18, 2020ClassClass IIStatusOngoingWhereNationwide, and Kansas and Ohio named
- Medical device recall FilmArray Gastronintestinal (GI) Panel Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Mississippi and New Jersey
- Medical device recall Concerto & Basic Shower Trolly The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of the arms of safety catch), which in certain… Class IIFDA’s classMar 18, 2020in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Georgia, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Oklahoma, Texas, Virginia and Wisconsin
- Medical device recall Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 Non-sterile product was shipped to customers. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Monoject Hypodermic Safety Needle 30G X 1/2” Non-sterile product was shipped to customers. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Monoject Hypodermic Safety Needle 25G x 5/8” Non-sterile product was shipped to customers. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia 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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