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 VITROS 3600 Chemistry System Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 5600 Chemistry System Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 4600 Chemistry System Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 5,1 FS Chemistry System Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Model NuCARTGN The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Georgia, Ohio and Tennessee named
- Medical device recall Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length Product on the package label did not match what was inside the package. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Idaho, Maine, Missouri, North Carolina, New York, Pennsylvania, South Carolina and Wisconsin
- Medical device recall RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer… Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer… Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0 Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iChem 10 SG Urine Chemistry Strips, PN 800-7005 Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJan 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm PMMA is listed as a material on the label but the product does not contain PMMA. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Illinois, Minnesota, Missouri, Ohio, Oklahoma, Pennsylvania, Utah and Washington named
- Medical device recall 0 deg, 8mm Endoscope, IS4000 This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 30 deg, 8mm Endoscope, IS4000 This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer… The product on the package label did not match what was inside the package. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereAlabama, Kentucky, Maine, Minnesota, Mississippi, New Mexico, New York and Ohio
- Medical device recall Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in… The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Wisconsin, West Virginia and Wyoming
- Medical device recall The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set… Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 13, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 13, 2016ClassClass IStatusTerminatedWhereAlaska, California, Florida, Indiana, North Carolina, New York, Oregon and Wisconsin
- Medical device recall CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim… Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and California and Michigan named
- Medical device recall Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED… One lot of 35 mm patella implants is labeled as 32 mm. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereFlorida, Indiana, Missouri and Texas
- Medical device recall Corflex Contender Post-Op Knee Brace Lite Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CONTENDER POST-OP-KNEE BRACE FULL FOAM Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Natus Quantum System with NeuroWorks Software During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with… Class IIFDA’s classJan 13, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, Colorado, Florida, Georgia, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Ohio, South Carolina, Tennessee, Texas and Utah
- Medical device recall Remote Patient Monitoring System, MDP 2000 Series Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap condition, not allowing system to reset and reboot. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Maryland, New Jersey, New Mexico and Ohio named
- Medical device recall InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage:… Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not… Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIRMINGHAM HIP RESURFACING MODULAR HEAD The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing… Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic… The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr Potential for separation of the proximal handle from the shaft. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler… Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGEN System A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented… Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i, PROVIDE PROTECTION CAP Inadequate biocompatibility testing. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOMET 3i, PROVIDE PROTECTION CAP KITS Inadequate biocompatibility testing. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOMET 3i, PROVIDE IMPRESSION COPINGS Inadequate biocompatibility testing. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOMET 3i, PROVIDE IMPRESSION COPING KITS Inadequate biocompatibility testing. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MED-RX Single Use The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Color Flow direction is displayed incorrectly in Lumify 1.0. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, North Dakota, Nevada, Oregon, Rhode Island, Tennessee and Washington
- Medical device recall Software version VD10E for Syngo X-Workplace Potential post-processing software issue when using tabcard “4D” on X-Workplace with software version VD10E. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch Device has the potential to have torn wings. Class IIIFDA’s classJan 13, 2016in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJan 13, 2016ClassClass IIIStatusTerminatedWhereTennessee
- Medical device recall ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Product mislabeled as latex free. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc Stability data does not substantiate the labeled two-year shelf life of affected product. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall AMSCO¿ Warming Cabinet The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the… Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a… When using the option “Tumor Overlap Fraction” in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target… Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, New York and Pennsylvania named
- Medical device recall Baxter Y-Type Spike Adapter, 7” Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxter INTERLINK System, Y-Type Solution Set, 78 Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. Class IIFDA’s classJan 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2016ClassClass 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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