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 NEO DELTA Self Safe, I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall NEO DELTA Self Safe 1, I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall NEO DELTA Self Safe T, I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall NEO DELTA SELFSAFE PUR 1, I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall NEO DELTA SELFSAFE PUR T, I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall NEO DELTA SELFSAFE PUR T, I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall WOLF-PAK Self Safe Safety IV Catheter: a) Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall EPIQ Ultrasound Systems Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedAug 25, 2021ClassClass IIStatusCompletedWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Oxygen Sensor Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic… The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FLASH Ostial System, Dual Balloon Angioplasty Catheter Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Montana, New York, Ohio, Pennsylvania, South Carolina and South Dakota named
- Medical device recall OPTI SARS-CoV-2 RT-PCR Test The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereAlabama, Connecticut, Florida, Georgia, Illinois, Maine, New Jersey, New York, Pennsylvania and Puerto Rico
- Medical device recall Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. Class IIIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 25, 2021ClassClass IIIStatusOngoingWhereNationwide, and California, District of Columbia, New Jersey and Oregon named
- Medical device recall NEO-KATH Epidural Catheter Set Potential for stylet to protrude from the distal end of the catheter Class IIFDA’s classAug 25, 2021in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 25, 2021ClassClass IIStatusCompletedWhereCalifornia, Delaware, Ohio, Oklahoma, Pennsylvania, Virginia, Washington and West Virginia
- Medical device recall NEO-KATH(TM) Caudal Set Potential for stylet to protrude from the distal end of the catheter Class IIFDA’s classAug 25, 2021in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 25, 2021ClassClass IIStatusCompletedWhereCalifornia, Delaware, Ohio, Oklahoma, Pennsylvania, Virginia, Washington and West Virginia
- Medical device recall 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume,… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York and Pennsylvania named
- Medical device recall Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume,… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York and Pennsylvania named
- Medical device recall 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume,… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York and Pennsylvania named
- Medical device recall 728332 IQon Spectral CT-Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume,… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York and Pennsylvania named
- Medical device recall 728333 Spectral CT 7500 -Computed Tomography X-ray system When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume,… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York and Pennsylvania named
- Medical device recall RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR’s) May show unexpected locus specific signals in addition to those at 19p13.3. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Kentucky, New York, Ohio, Texas, Utah and Virginia named
- Medical device recall CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia named
- Medical device recall EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11 EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia named
- Medical device recall ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses Mislabeled: Labeled on the package as 60mm contains 45mm devices Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Maryland and Washington named
- Medical device recall TheraSphere Administration Set Potential for leaks and loosening at the patient catheter connection Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TheraSphere Administration Set Potential for leaks and loosening at the patient catheter connection Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Triathlon Prim CEM FXD BPLT 7 The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Colorado, Minnesota, Mississippi, New Jersey, Oklahoma, Pennsylvania and Texas named
- Medical device recall Spectrum IQ Infusion System with Dose IQ Safety Software System errors were noted following changes the customers implemented to the configuration of their network and server systems. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico
- Medical device recall Dose IQ Safety Software used with Spectrum IQ Infusion Pump Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HeartWare HVAD Pump Implant Kit Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartWare HVAD Pump Implant Kit Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartWare HVAD Pump Implant Kit Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartWare HVAD Pump Implant Kit Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartWare HVAD Driveline Extension Cable Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartWare HVAD Driveline Extension Cable Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartWare HVAD Implant Kit Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartWare HVAD Implant Kit Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartWare HVAD Outflow Graft Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartWare HVAD Pump Accessories Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Alaris Infusion Pump Module Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWhereCalifornia, Illinois, Indiana, Kentucky, Louisiana, New Jersey, Nevada, Ohio and Pennsylvania
- Medical device recall Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgistool-intended to support a healthcare professional during surgical procedures Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure,… Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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