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 Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered,… Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a… Correction vector confirmation message is lost if access point is changed after sending the correction vector. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient… To correct the kit’s instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report29 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LigaSure” Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument… Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality… Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control… Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LFIT Anatomic CoCr Femoral Heads, 6260-9-036 The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LFIT Anatomic CoCr Femoral Heads The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LFIT Anatomic CoCr Femoral Heads The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LFIT Anatomic CoCr Femoral Heads The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LFIT Anatomic CoCr Femoral Heads The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LFIT Anatomic CoCr Femoral Heads The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LFIT Anatomic CoCr Femoral Heads The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LFIT Anatomic CoCr Femoral Heads The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in) The incorrect IFU was shipped with the product. Class IIIFDA’s classJul 11, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 11, 2018ClassClass IIIStatusTerminatedWhereCalifornia, Illinois, Louisiana, South Carolina, Texas and Wisconsin
- Medical device recall ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm The incorrect IFU was shipped with the product. Class IIIFDA’s classJul 11, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 11, 2018ClassClass IIIStatusTerminatedWhereCalifornia, Illinois, Louisiana, South Carolina, Texas and Wisconsin
- Medical device recall St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is… The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device… The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are… The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Angio-Seal Evolution Vascular Closure Device Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Indiana, Michigan, Missouri, North Carolina, New York, South Dakota, Tennessee and Texas
- Medical device recall Cannulated Driver Handle Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report22 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Florida, Georgia, Iowa, Kansas, Massachusetts, Minnesota, Missouri, Montana, Nebraska, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Ratcheting Cannulated Driver Handle Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report22 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Florida, Georgia, Iowa, Kansas, Massachusetts, Minnesota, Missouri, Montana, Nebraska, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall GE Healthcare CARESCAPE Monitor B650 When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall da Vinci X Surgical System Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Iowa, Illinois, Minnesota, Mississippi, Nebraska, Oklahoma, Tennessee and Texas named
- Medical device recall Safety Sideport Knife 1.0mm 45¿ Blades are loose in handles and may fall out due to non cured epoxy Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Hawaii, Iowa, Maryland and Texas named
- Medical device recall 26-Lead Transfer Set for use with APEX¿ Compounding System, Product There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, Texas and Washington
- Medical device recall VITROS Chemistry Products PHYT Slides There is a potential for imprecise results when using the slides. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall microTargeting” Drive System, Product Number MT-DS The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” Drive System, Product Number MT-DS-01 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” Drive System, Product Number 66-ZD-MD The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” Drive System, Product Number 66-ZD-MD-01 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” STar” Drive System (Manual), Product Number ST-DS-MA The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” STar” Drive System (Motorized), Product Number ST-DS-ME The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” STar” Drive System (Manual), Product Number 70-ZD-MA The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” STar” Drive System (Motorized), Product Number 70-ZD-ME The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” Lead Adapter for microTargeting” Drive, Product Number 66-CN-DB The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” Lead Adapter for STar” Drive, Product Number 70-CN-DB The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” Drive System The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” Drive System The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” STar” Drive System (Manual) The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microTargeting” STar” Drive System (Motorized) The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall microtargeting” Depth Stop Adapter, Product The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline… Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Oregon, Rhode Island, Texas and Vermont
- Medical device recall Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6 M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for… Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNo state 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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