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 cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602:… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VIA 27 Microcatheter Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Kansas, Maryland, Minnesota, Missouri, North Carolina, New York, Ohio, Tennessee and West Virginia
- Medical device recall Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura… St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model… St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Quadra Assura St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes AccessClosure, Inc. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereFlorida and New Jersey
- Medical device recall Neptune Plus (Hemostatic Pad) Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Missouri, Mississippi, North Carolina, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas and West Virginia named
- Medical device recall Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Massachusetts, Minnesota, North Dakota, Nevada, New York, Pennsylvania and Virginia named
- Medical device recall enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module… Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch” Tip (SPSA-20002590) Provide… The cleaning instructions provided in FemTouch Operator’s Manual might be ineffective for a fully assembled device and may lead to a potential for… Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ex-TEM Assay for ROTEM delta Thromboelastometry System Customers complained of low/empty reagent vials. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, District of Columbia, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall ReTurn 7500/7500 Aid, transfer During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereConnecticut, Illinois, Maine, Nebraska, New Jersey, Nevada, New York and Pennsylvania
- Medical device recall 4205 Journey Rolling Walker Product Usage: used to assist people in walking Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Symbiq One Channel Infuser Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Symbiq Two Channel Infuser Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect… Class IIIFDA’s classNov 2, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 2, 2016ClassClass IIIStatusTerminatedWhereAlabama, California, Colorado, Kentucky, Maryland, Michigan, Mississippi, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Washington and Wisconsin
- Medical device recall PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date… Class IIIFDA’s classNov 2, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 2, 2016ClassClass IIIStatusTerminatedWhereAlabama, California, Colorado, Kentucky, Maryland, Michigan, Mississippi, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Washington and Wisconsin
- Medical device recall VITROS Immunodiagnostic Products HBsAg Controls The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Class IIIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall SimpliRED D-Dimer A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereConnecticut and Indiana
- Medical device recall da Vinci¿ Xi” Surgical System Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip… Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 2, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Safil QUI + UNDY 5/0 There is a potential for the needle to detach from the suture thread during surgery. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportArizonathe one state its words name PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereArizona
- Medical device recall Zimmer¿ Gender Solutions” Patellofemoral Joint Prosthesis Milling Handpiece Complaints have been reported that the handpiece is inoperable. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source),… PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing… Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens… Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay… Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN… Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay… Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Skintact Electrodes for Defibrillation, DF29N There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportFloridathe one state its words name PublishedOct 26, 2016ClassClass IStatusTerminatedWhereFlorida
- Medical device recall HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation… Loose connector ports in controller body. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedOct 26, 2016ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a… The connector may disconnect from the tracheostomy tube during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IStatusTerminatedWhereNationwide, and California named
- Medical device recall Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230 Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Vascular Solutions Twin-Pass RX Dual Access Catheter Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Vascular Solutions Twin-Pass .023” Dual Access Catheter Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin… The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereFlorida, Georgia, Maryland, Pennsylvania, Texas and Virginia
- Medical device recall SDMS (SenTec Digital Monitoring System) Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereLouisiana, Michigan, Missouri, Ohio and Tennessee
- Medical device recall VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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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