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 BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 22301, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 22300, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall Gentle Threads, Interference Screw Specific lots of the device were overexposed during EtO sterilization. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gentle Threads, Interference Screw Specific lots of the device were overexposed during EtO sterilization. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gentle Threads, Interference Screw Specific lots of the device were overexposed during EtO sterilization. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gentle Threads, Interference Screw Specific lots of the device were overexposed during EtO sterilization. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gentle Threads, Interference Screw Specific lots of the device were overexposed during EtO sterilization. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gentle Threads, Interference Screw Specific lots of the device were overexposed during EtO sterilization. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ReNew Dolphin Nose Disposable Dissector Tip Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, Michigan, Ohio, Oklahoma and Tennessee
- Medical device recall ReNew Endocut Scissor Disposable Tip Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, Michigan, Ohio, Oklahoma and Tennessee
- Medical device recall ZYMUTEST HIA MonoStrip IgG Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereMaryland, North Carolina, New Hampshire, New York and Ohio
- Medical device recall ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent… Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereMaryland, North Carolina, New Hampshire, New York and Ohio
- Medical device recall ZYMUTEST HIA IgGAM Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereMaryland, North Carolina, New Hampshire, New York and Ohio
- Medical device recall LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is… Reports of product loosening or coming unscrewed from the handle. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Ohio and Washington named
- Medical device recall Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Georgia, Indiana, Louisiana, Maryland and Wyoming named
- Medical device recall Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to… Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Nebraska, Nevada, New York and Texas
- Medical device recall Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is… Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Nebraska, Nevada, New York and Texas
- Medical device recall Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to… Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Nebraska, Nevada, New York and Texas
- Medical device recall Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to… Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Nebraska, Nevada, New York and Texas
- Medical device recall Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended… Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Nebraska, Nevada, New York and Texas
- Medical device recall Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended… Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Nebraska, Nevada, New York and Texas
- Medical device recall AEQUALIS HUMERAL NAIL DRILL BIT Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Retractor f/Sciatic Nerve There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Retractor f/Sciatic Nerve Long There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended… The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended… The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a… When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, North Carolina, Nebraska, New York and Washington
- Medical device recall Transonic ADT1018 Flow QC Clear Advantage Tubing The sterility of the device cannot be assured. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York, Ohio, Pennsylvania and Texas 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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