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 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Sedecal SA Mobile Diagnost w DR x-ray system Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report30 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, Washington and Wisconsin
- Medical device recall Philips Healthcare DigitalDiagnost stationary X-ray system The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New York, Ohio, Pennsylvania and Washington named
- Medical device recall Philips Healthcare DuraDiagnost stationary X-ray system The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New York, Ohio, Pennsylvania and Washington named
- Medical device recall Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products. Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Michigan, Missouri, New Hampshire, New Jersey, New York, Oklahoma and Pennsylvania named
- Medical device recall Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products. Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Michigan, Missouri, New Hampshire, New Jersey, New York, Oklahoma and Pennsylvania named
- Medical device recall Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and Washington
- Medical device recall Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and Washington
- Medical device recall Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and Washington
- Medical device recall Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and Washington
- Medical device recall Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and Washington
- Medical device recall Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and Washington
- Medical device recall Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and Washington
- Medical device recall The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as… Firm’s investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide,… Firm’s investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stryker FlowPort II Adapter Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereGeorgia, Maryland, Montana, New Jersey and Utah
- Medical device recall Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The… Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 3600 Immunodiagnostic System Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography… GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, North Carolina, Nebraska, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Liko Universal SlingBars Universal SlingBar” 350, Universal SlingBar” 350 QRH, Universal SlingBar” 350 R2R,… The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Idaho, Illinois, Indiana, Massachusetts, Montana and Tennessee named
- Medical device recall Persona Trabecular Metal Tibia Zimmer Inc. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report30 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5… Labeling errors. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Delaware, Illinois, Kansas, Michigan, Missouri, North Carolina, New Jersey, Oklahoma, Pennsylvania, South Carolina, Texas, Utah and Wisconsin named
- Medical device recall 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5… Labeling errors. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Delaware, Illinois, Kansas, Michigan, Missouri, North Carolina, New Jersey, Oklahoma, Pennsylvania, South Carolina, Texas, Utah and Wisconsin named
- Medical device recall 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5… Labeling errors. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Delaware, Illinois, Kansas, Michigan, Missouri, North Carolina, New Jersey, Oklahoma, Pennsylvania, South Carolina, Texas, Utah and Wisconsin named
- Medical device recall Oxoid Nitrocefin (+ Reconstitution Fluid Batch) Individual bottles of product may produce weak beta-lactamase reactions. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportMissourithe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for… Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 4 ml FX Sodium Fluoride/Potassium Oxalate tube The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Kentucky, New York, Pennsylvania, Puerto Rico and Virginia named
- Medical device recall Tearaway Introducer This recall has been initiated due to the product labeled with the incorrect expiration date. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereFlorida, North Carolina and Texas
- Medical device recall Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that’s secure two underlying fabrics, which would be captured on certain scans on… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic RestoreSensor Loss of therapy during recharging of device. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MSK 1.5T Extreme MR Scanner, a diagnostic imaging device The gas venting may not occur properly. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report25 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Iowa, Idaho, Illinois, Maine, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Optima 1.5T MR430s MR Scanner, a diagnostic imaging device The gas venting may not occur properly. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report25 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Iowa, Idaho, Illinois, Maine, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall ExacTrac Vero is a Patient Positioning System for Radiation therapy. Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereFlorida, New York, Ohio and Texas
- Medical device recall Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the… Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the… Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the… Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the… Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Triglyceride Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic… It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general… BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medical device recall Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general… BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medical device recall Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report23 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Oklahoma, Pennsylvania, Rhode Island, Texas and Utah
- Medical device recall Maestro Air Motor Pneumatic cranial drill motor Due to the buildup of grease within the hose and motor, the product may require multiple attempts to start. Class IIFDA’s classJun 15, 2016in FDA’s Enforcement Report22 statesnamed in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, North Carolina, New Mexico, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set. A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportIndianathe one state its words name PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereIndiana
- Medical device recall Norian Drillable Inject 3 CC-Sterile DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Norian Drillable Inject 5 CC-Sterile DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia 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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