Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Single Chamber Temporary External Pacemaker A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Current, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ellipse, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fortify, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fortify Assura, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Promote, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Promote Quadra, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Quadra Assura, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Quadra Assura MP, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Unify, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Unify Assura, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Unify Quadra, Sterile EO The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merlin PCS programmer (Model # 3650), Software (Model # 3330) The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to… Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807 The firm received a customer complaint of observed spots on the wipes. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the… Invalid calibration with low calibrator S1 while using the product. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportKentuckythe one state its words name PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereKentucky
- Medical device recall DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants… The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DRILL PT GUIDE WIRE 2MM X 60CM The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BALL TIP GUIDE WIRE 3.2MMX98CM The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BALL TIP GUIDE WIRE 3.2MMX55CM The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GUIDE WIRE w/ BALL TIP 2.0MMX98CM The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BALL TIP GUIDE WIRE 2.0MMX60CM The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall G-PIN 2.8BL 3.2PL 60CM 2PK The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall G-PIN 2.8BL 3.2PL 98CM 2PK The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall G-PIN 2.8BL 3.2PL 98CM 2PK The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BEAD TIP GD WIRE 3.0MM X 60CM The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.2MM X 510MM COCR THD TIP The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RECON DRILL 6MM X 439MM The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.2MM X 560MM COCR THD TIP The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CritiCore Automated Urine Output and Temperature Monitor Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report23 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Florida, Georgia, Hawaii, Indiana, Kansas, Louisiana, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Ohio, Oklahoma, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Farabeuf Clamp for 3.5mm Screws PRO Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereArkansas, California, Idaho, Illinois, Maryland, Michigan, New Jersey, New York, Oklahoma, South Dakota and Texas
- Medical device recall Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Indiana, Kansas, Louisiana, Maryland, North Carolina, Nebraska, New Jersey, Oregon, Texas and Virginia
- Medical device recall Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Indiana, Kansas, Louisiana, Maryland, North Carolina, Nebraska, New Jersey, Oregon, Texas and Virginia
- Medical device recall Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Indiana, Kansas, Louisiana, Maryland, North Carolina, Nebraska, New Jersey, Oregon, Texas and Virginia
- Medical device recall Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph… Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Drainer(R) Centesis Catheters: (a) The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fabius GS Premium Anesthesia Machine The Draeger anesthesia device may be able to dose 100% N2O. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall Fabius GS Tiro Anesthesia Machine The Draeger anesthesia device may be able to dose 100% N2O. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall Fabius GS MRI Anesthesia Machine The Draeger anesthesia device may be able to dose 100% N2O. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall Apollo Anesthesia Machine The Draeger anesthesia device may be able to dose 100% N2O. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall Perseus A500 Anesthesia Machine The Draeger anesthesia device may be able to dose 100% N2O. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall VNS Therapy Programmer Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report21 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Maine, Missouri, Mississippi, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall C2 CryoBalloon Focal Catheter The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care… The kits contained an incorrect lot of Dropper Plus Level 1 vials Class IIIFDA’s classJun 27, 2018in FDA’s Enforcement ReportKansasthe one state its words name PublishedJun 27, 2018ClassClass IIIStatusTerminatedWhereKansas
- Medical device recall The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that… Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Indiana, Pennsylvania, Puerto Rico and US Virgin Islands named
- Medical device recall The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that… Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Indiana, Pennsylvania, Puerto Rico and US Virgin Islands named
- Medical device recall The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that… Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Indiana, Pennsylvania, Puerto Rico and US Virgin Islands named
- Medical device recall P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation… Missing drill guide as stated in the package. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the… Class IIFDA’s classJun 27, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kansas, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, Pennsylvania, Texas, Utah and Washington
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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