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 PRECISE PRO RX CAROTID STENT implant system Distal tip may become separated from the lumen wire in specific lots. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 24, 2021ClassClass IStatusCompletedWhereNo state named
- Medical device recall HeartSpan Transseptal Needles The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement Report18 statesnamed in where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, District of Columbia, Georgia, Kentucky, Louisiana, Maryland, Michigan, Montana, Nebraska, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Heartspan Transseptal Needles The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement Report18 statesnamed in where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, District of Columbia, Georgia, Kentucky, Louisiana, Maryland, Michigan, Montana, Nebraska, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 Defect in the mechanical assembly of the needle holder contained in the navigation kit. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNew Jersey, New York and Wisconsin
- Medical device recall Incisive CT Computed Tomography X-ray System Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack… VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Carestream Dental CS 3600 Single Use Normal Tips The mirror may become detached and fall from the unit Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Idaho, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Washington and West Virginia named
- Medical device recall Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 24, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery… The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of… Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and… Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida and Kentucky named
- Medical device recall Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 Potential false positive HSV results. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Illinois, Maryland, New Jersey, New York, Tennessee and Texas
- Medical device recall SIROS D-Vial Prep Set There is a potential presence of particulate matter in the D-Vial. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Feth-R-Kath Catheter, 19g x 24” Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall System INFX-8000V The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall System INFX-8000C The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall System INFX-8000F The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product… Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the… Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage:… Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the… Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage:… Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the… Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage:… Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the… Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the… Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures… Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Massachusetts, Michigan, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia named
- Medical device recall SUNSTAR G.U.M The product may be contaminated with Burkholderia cepacia Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral… Incorrect lot of Substrate Reagent (TMB) may be included in the kit. Class IIIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 17, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Kansas, New Jersey, Ohio and Virginia named
- Medical device recall Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide… The 5F Dignity CT Port kits were packaged with the incorrect size port. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide, and California, District of Columbia, Georgia, Illinois, Indiana, Massachusetts, Michigan, New Jersey, New Mexico, New York, Ohio, Pennsylvania and Texas named
- Medical device recall ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within… Class IIFDA’s classMar 17, 2021in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Indiana, North Carolina, New Jersey, New York and Oregon
- Medical device recall Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer. Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereArizona, Georgia, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, Oregon, Pennsylvania, South Carolina, Utah, Washington and West Virginia
- Medical device recall Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the… Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, New York, Ohio and Oregon named
- Medical device recall Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of… Siemens Healthcare Diagnostics Inc. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and… Due to complaints received regarding missing lid magnets which may result in premature battery depletion. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Thread-like wire marker This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNew Jersey and Ohio
- Medical device recall Valiant Navion Thoracic Stent Graft System Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cascadion SM Clinical Analyzer Due to software defect, under certain assay parameters, false Vitamin D results may be reported. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Omnipod DASH Insulin Management System User Guide (OUS Only) Product Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 17, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage:… Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Class IIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 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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