Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall TIGR Matrix Surgical Mesh Novus Scientific is implementing additions to the product’s instructions for use concerning certain inguinal hernia repairs. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kentucky, Missouri, North Carolina, New Hampshire, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall CARESCAPE VC150 Vital Signs Monitor A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee and Wisconsin
- Medical device recall Panacea Air Pro Mattress Control Unit The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArizona, Colorado, Iowa, Idaho, Illinois, Louisiana, Maryland, Minnesota, Mississippi, Ohio, Pennsylvania, Texas, Washington, Wisconsin and Wyoming
- Medical device recall Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized… The outer packaging was mislabeled on the box indicating “Cobalt HV with Gentamicin”. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radiesse (+) Lidocaine, Injectable Implant 1.5cc Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with… The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report26 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Texas, Utah and Virginia
- Medical device recall 1) The HomeChoice automated peritoneal dialysis system In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire,… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons… Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition AS with software version VA48A-SP2 Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereCalifornia, Kentucky, Michigan, North Dakota, Nebraska and New York
- Medical device recall SOMATOM Definition Flash with software version VA48A-SP2 Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereCalifornia, Kentucky, Michigan, North Dakota, Nebraska and New York
- Medical device recall SOMATOM Definition Edge with software version VA48A-SP2 Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereCalifornia, Kentucky, Michigan, North Dakota, Nebraska and New York
- Medical device recall RadSuite software Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee and Virginia
- Medical device recall OEC UroView 2800, fluoroscopic x-ray system A firmware issue in the supplied LCD workstation monitor(s). Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OEC 9800, fluoroscopic x-ray system A firmware issue in the supplied LCD workstation monitor(s). Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 120 V Neptune 3 Rover Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereCalifornia, Iowa, Idaho and Michigan
- Medical device recall RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, Massachusetts and Minnesota
- Medical device recall RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, Massachusetts and Minnesota
- Medical device recall RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, Massachusetts and Minnesota
- Medical device recall RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, Massachusetts and Minnesota
- Medical device recall TIBIAL TRAY , SIZE 2 The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, Massachusetts and Minnesota
- Medical device recall TIBIAL TRAY , SIZE 3 The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, Massachusetts and Minnesota
- Medical device recall TIBIAL TRAY , SIZE 4 The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, Massachusetts and Minnesota
- Medical device recall TIBIAL TRAY , SIZE 5 The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, Massachusetts and Minnesota
- Medical device recall Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Rhode Island, Texas, Utah, Virginia and Washington
- Medical device recall Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Rhode Island, Texas, Utah, Virginia and Washington
- Medical device recall Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Rhode Island, Texas, Utah, Virginia and Washington
- Medical device recall Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Rhode Island, Texas, Utah, Virginia and Washington
- Medical device recall Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Rhode Island, Texas, Utah, Virginia and Washington
- Medical device recall Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Rhode Island, Texas, Utah, Virginia and Washington
- Medical device recall DBS Pocket Adaptor Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for… The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Maryland and Missouri named
- Medical device recall BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for… The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Maryland and Missouri named
- Medical device recall BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for… The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Maryland and Missouri named
- Medical device recall BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for… The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Maryland and Missouri named
- Medical device recall Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico 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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