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 GastriSail” Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated… Reports of gastric or esophageal perforation occurring in procedures where the GastriSail” Gastric Positioning device has been used. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Allen Medical Bow Frame The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radiolucent Surgery Spine Frame (F70801) The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pentax Video Duodenoscope The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended… Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT… Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T… Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multi Lumen Central Venous Catheterization Kit These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps… These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and… These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow Multi Lumen CVC Kit (Central venous catheter) These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AGB+ Multi Lumen Central Venous Catheterization Kit These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter) These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Central Venous Catheterization Kit with Blue FlexTip Catheter These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions These finished good kits may contain the incorrect Springwire Guide (SWG). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates… FUJIFILM Medical Systems U.S.A., Inc. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR… FUJIFILM Medical Systems U.S.A., Inc. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500)… FUJIFILM Medical Systems U.S.A., Inc. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography… FUJIFILM Medical Systems U.S.A., Inc. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total… There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts, Maine, Michigan, Minnesota and Wisconsin
- Medical device recall Sorin Group Smart Perfusion Pack E-Pack The product is labeled with the incorrect expiration date. Class IIIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportLouisianathe one state its words name PublishedFeb 28, 2018ClassClass IIIStatusTerminatedWhereLouisiana
- Medical device recall Heliomolar Refill 20x0.25g 110/A1 Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the… Class IIIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Heliomolar Refill 20x0.25g 140/A2 Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the… Class IIIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Heliomolar Refill 20x0.25g 210/A3 Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the… Class IIIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Heliomolar Refill 20x0.25g 110T Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the… Class IIIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall LCP Drill Sleeve 1.5 Drill Bit 1.1mm May have difficulty attaching the drill sleeve to the plate. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software… Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Protura Software which utilizes Elekta’s iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2,… When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereIowa and South Dakota
- Medical device recall Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract… There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75 Knee implant components (tibial bearings) are labeled with the incorrect size. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Ohio, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75 Knee implant components (tibial bearings) are labeled with the incorrect size. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Ohio, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Cobas 8000 Modular Series system A software failure may incorrectly set the system settings to “default” settings, creating a risk of incorrect results. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Rapid for the TLiIQ(R) System, HOLOGIC(R) Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportGuamthe one state its words name PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereGuam
- Medical device recall Rapid for the TLiIQ(R) System, HOLOGIC(R) Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportGuamthe one state its words name PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereGuam
- Medical device recall Nutrisafe 2 35 mL Syringe for Safety Connection Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 20Ga x .75 LifeGuard Huber Needle with Y-site Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CVC Tray Pediatrics Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 19Ga x 1 Huber Needle Set Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 3-Way Standardbore Stopcock Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips… Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips… Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Innova Self-Expanding Stent System, 200 mm Stent possibly unable to be fully released from the delivery system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 28, 2018ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Innova Self-Expanding Stent System, 180mm Stent possibly unable to be fully released from the delivery system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 28, 2018ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Nitinol TC Reusable Electrodes (TCN) After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
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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