Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a… Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy,… Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart XL+ Defibrillator/Monitor A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereIndiana and Washington
- Medical device recall Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 16, 2014ClassClass IStatusTerminatedWhereNationwide, and New York and Wisconsin named
- Medical device recall FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smiths Medical HOTLINE¿ Fluid Warming Set L-70 Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Idaho and Indiana named
- Medical device recall Smiths Medical HOTLINE¿ Fluid Warming Set L-80 Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Idaho and Indiana named
- Medical device recall Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions,… Alcon LenSx received reports of unexpected downward motion of the gantry. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Economy Elastic Knee Sleeve Open Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky and Texas named
- Medical device recall K-Lite Knee 2 Stays with Visco Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky and Texas named
- Medical device recall Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft) The Male Components in this lot are made of material with lower strength than manufacturing specifications. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Missouri and Texas named
- Medical device recall Cobas c8000 Modular Analyzer Series Cobas c502 The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage:… MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to 11/7/2012 do not meet MedCare’s high standards. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Mississippi, North Dakota, Nebraska, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas and Wisconsin named
- Medical device recall Sit/stand Rolling Walker Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold June 2009 to March 2014) because, over time, there is the… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reusable latex breathing bags with multiple Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita… The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0 Potential for dose errors due to software program errors. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Delaware, Florida, Illinois, Maryland, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee and Washington
- Medical device recall RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereFlorida, Illinois, Massachusetts, Maryland, New Jersey, Ohio and Washington
- Medical device recall Artis Zee Angiographic x-ray systems. An inappropriate cable connection was assembled for certain Artis zee systems. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Pennsylvania and Wisconsin
- Medical device recall TDWorkstation version 11.01.A or higher If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an… Class IIIFDA’s classApr 9, 2014in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 9, 2014ClassClass IIIStatusTerminatedWherePennsylvania
- Medical device recall Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version… Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement Report49 statesnamed in where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Infantino Squeeze & Teethe Monkey, “Go Gaga Squeeze & Teether Coco the Monkey” Infantino initiated this voluntary recall of all lots of Infantino Squeeze & Teethe Monkey, “Go Gaga Squeeze & Teethe Coco the Monkey”, Model Number 206-647,… Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter… The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Omni Micro-electrode/reference electrode for cobas b221 analyzer Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall IMMULITE 2000 There is a potential for incorrect results to be reported from processing of a sample tube. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3 Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging… Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3M” Steri-Vac” Gas Sterilizer/Aerators Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M” Steri-Vac” Gas Sterilizers. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, South Carolina, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Pressure Monitoring Tubing, PM6006 The products are labeled as sterile but were not sterilized. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Wisconsin named
- Medical device recall Merit Custom Syringe Kit, Convenience Kit, I.R The products are labeled as sterile but were not sterilized. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Wisconsin named
- Medical device recall Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0 Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on… Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Integrity 1.1 The problem is that the “static tolerances” from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, Connecticut, Florida, Georgia, Kentucky, Louisiana, Maryland, Missouri, North Carolina, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm Complaints of leakage of insufflation gas through the device. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 10mm Weck Vista Cannula-only Complaints of leakage of insufflation gas through the device. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port Complaints of leakage of insufflation gas through the device. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 5/10 mm Weck Vista Universal Cannula Complaints of leakage of insufflation gas through the device. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access Complaints of leakage of insufflation gas through the device. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length Complaints of leakage of insufflation gas through the device. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Proceed Surgical Mesh The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination. Class IIFDA’s classApr 9, 2014in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 9, 2014ClassClass IIStatusOngoingWhereAlabama, California, Florida, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and West Virginia
- Medical device recall Spirit MB Bracket, UR Central +14T +5A.018 Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as… Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348) ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the… Class IIFDA’s classApr 9, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 9, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Missouri, New York, Ohio, Tennessee, Utah and Washington named
- Medical device recall HeartMate II Implant Kit with Pocket Controller Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 2, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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 HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood… Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 2, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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 Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device… Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 2, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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
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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