Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER,IS4000 Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier’s recall because of potential breach in… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier’s recall because of potential breach in… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier’s recall because of potential breach in… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall EYE KIT The Covidien Curity Oval Eye Pads are individually Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier’s recall because of potential breach in… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier’s recall because of potential breach in… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier’s recall because of potential breach in… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier’s recall because of potential breach in… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall Bond Elut OMS (Dried Matrix Spotting)’ Product The product was marketed without 510(k) clearance. Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DX-D600 - DXD Imaging Package One of the dent markers from the DX-D600 dropped down from the overhead rail. Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report24 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Missouri, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Covidien Curity Eye Pad Product sterility is compromised due to breach of sterile barrier Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 Product sterility is compromised due to breach of sterile barrier Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Curity Eye Pad Product sterility is compromised due to breach of sterile barrier Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Curity Wet Dressing 8 x 4 Product sterility is compromised due to breach of sterile barrier Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Kerlix Super Sponge Saline Dressing, Sterile Product sterility is compromised due to breach of sterile barrier Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 Product sterility is compromised due to breach of sterile barrier Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Curity Saline Dressing 8’ x 4 Product sterility is compromised due to breach of sterile barrier Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer Buffered Sodium Citrate BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens ADVIA Centaur BR assay Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens ADVIA Centaur BR assay Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens ADVIA Centaur BR assay Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BrightView SPECT The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall BrightView XCT The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall BrightView X 3/4 The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the… Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall BrightView X 3/8 The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the… Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall HeartStart MRx Monitor/Defibrillator HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 5, 2017ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall XTRAC Excimer Laser When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 7F Prelude¿ Short Sheath Introducer Merit Medical Systems, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
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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