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 8, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall Synthes Small Electric Drive (SED) May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Florida, Hawaii, Idaho, Illinois, Kansas, Louisiana, Michigan, North Carolina, New York, Texas, Virginia and Washington
- Medical device recall CDI H/S Cuvette, non-sterile The CDI System 500 monitor displays the “H/S DISCONNECT AT CUVETTE” error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S… Class IIIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6 When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. The system loaded a completion fraction in the incorrect order after a treatment interruption. Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Missouri and Wisconsin
- Medical device recall EVOLIS Microplate System The error “Washer Reagent Clean Fluid” level low alarmed, which prompted the customer to open the system drawer. Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Bond Polymer Refine Red Detection DS9390 kits The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Exactech Acapella One Interbody Fusion Device Parallel Incorrect external and internal packaging labels. Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereFlorida and Pennsylvania
- Medical device recall Actuator for angiographic x-ray monitor ceiling suspension system The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position. Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5) Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use Report by a customer of an open package seal. Class IIIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedFeb 24, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Dual Stage Venous Return Catheter, Low-Profile, wire reinforced Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case. Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Jadak Barcode Scanner Customers reported issues when scanning medications with the scanners. Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CEA / CD66e Ab-2 Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250. Class IIIFDA’s classFeb 24, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 24, 2016ClassClass IIIStatusTerminatedWhereArizona, California, Georgia, Kentucky, Massachusetts, Mississippi, New York, Pennsylvania and Texas
- Medical device recall LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereKansas, Ohio, Tennessee and Wisconsin
- Medical device recall MEE-1000A Neuromaster The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall High Flow Irrigation Extender During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization… Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Florida, Georgia, Idaho, Illinois, Kansas, Massachusetts, Michigan, Missouri, North Carolina, Tennessee and Texas
- Medical device recall Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Endo GIA Ultra Universal Standard Stapler Handle Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product… Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use Class IIFDA’s classFeb 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin… Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medical device recall INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and New York and Ohio named
- Medical device recall 2.3mm Turbo-Power OTW, Manual The product is labeled with an expiration date that is past its shelf life. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina and Pennsylvania named
- Medical device recall Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and… Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereMassachusetts and Texas
- Medical device recall Arctic Sun 5000 and Arctic Sun 2000 Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall VS200 radiographic Cassette Holder or Wall Stand The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VS300 radiographic Cassette Holder or Wall Stand The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mavig Monitor Suspension System GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Philips Allura Xper FD20 Ceiling version only Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereIndiana and Tennessee
- Medical device recall Allura Xper FD OR Table, Ceiling version only Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereIndiana and Tennessee
- Medical device recall Philips Healthcare TraumaDiagnost If arm is not fastened securely it could fall down. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Kansas, Massachusetts, New York, Rhode Island, Texas and Wisconsin
- Medical device recall MEVION S250 Radiation therapy system The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri, New Jersey and Oklahoma named
- Medical device recall GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic… Potential safety latch mechanism failure. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereDistrict of Columbia, Guam, Puerto Rico and US Virgin Islands
- Medical device recall GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic… Potential safety latch mechanism failure. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereDistrict of Columbia, Guam, Puerto Rico and US Virgin Islands
- Medical device recall GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic… Potential safety latch mechanism failure. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereDistrict of Columbia, Guam, Puerto Rico and US Virgin Islands
- Medical device recall CyberKnife Robotic The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming 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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