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 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM The product inside the package is incorrect. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereCalifornia, Michigan and Oklahoma
- Medical device recall M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length Potential failure of sterile packaging seal. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients… When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken… Class IIFDA’s classMay 2, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereIllinois, New Jersey, Virginia and Washington
- Medical device recall Flowmeter Module (accessory to Terumo Advanced Perfusion System 1) Inaccurrate flow readings. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky and Michigan
- Medical device recall Medtronic DxTerity Diagnostic Catheter, JL 4.0 The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Oncomine Dx Target Test, (Model No The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereArizona, California, North Carolina, Texas and Virginia
- Medical device recall Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for… The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur CA 125II Assay Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TCC-EZ, Total Contact Cast System A quarantined lot of the devices was released for sale. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MicroVue CIC-C1q EIA There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereColorado, New York, Texas and Utah
- Medical device recall MicroVue CIC-C1q EIA A component of the kit was found to contain bacterial contamination. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Iowa, Illinois, Minnesota, Missouri, North Carolina, New York, Ohio, Texas and Utah named
- Medical device recall MicroVue SC5b-9 Plus EIA (RUO) A component of the kit was found to contain bacterial contamination. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Iowa, Illinois, Minnesota, Missouri, North Carolina, New York, Ohio, Texas and Utah named
- Medical device recall MicroVue SC5b-9 Plus EIA (CE-IVD) A component of the kit was found to contain bacterial contamination. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Iowa, Illinois, Minnesota, Missouri, North Carolina, New York, Ohio, Texas and Utah named
- Medical device recall T4 Pullover Toga, (S/M) Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T4 Pullover Toga, L/XL Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T4 Pullover Toga, Regular Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T4 Pullover Toga, Large Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T4 Pullover Toga, X-Large Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T4 Zipper Toga (S/M) Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T4 Zipper Toga, (L/XL) Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T5 Zipper Toga with Peel-Away Face Shield, (L/XL) Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T4 Zipper Toga, Regular Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T4 Zipper Toga, X-Large Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T5 Zipper Toga with Peel-Away Face Shield, (XL/T) Separation of material layers may occur, causing a potential risk of exposure to contaminants. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System,… Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in… Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall FilmArray BCID Panel (Blood Culture Identification Panel) There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stem Extractor f/Guide Bar There is a potential for the connection screw of the stem extractor to break. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses… The secondary packaging is labeled with an incorrect expiration date. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti… The secondary packaging is labeled with an incorrect expiration date. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day… The secondary packaging is labeled with an incorrect expiration date. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day… The secondary packaging is labeled with an incorrect expiration date. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are… Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Quidel MicroVue Intact PTH EIA There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter Incorrect product labeling. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Delaware, Florida, Georgia, Idaho, Illinois, Kentucky, Michigan, Missouri, New Hampshire, New Jersey, Pennsylvania, Rhode Island, Texas and Utah named
- Medical device recall Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereConnecticut, Florida, Georgia, Indiana, Massachusetts, Michigan, New York and Texas
- Medical device recall Versatex Monofilament Mesh 50 x 50cm, Product No There have been patient reports of abdominal hernia recurrence following hernia repair. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin 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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