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 Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant… Potential collision risk when using XVI and external beam shaping devices. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular… Lens was manufactured with incorrect raw material. Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gelzone Shoulder Sleeve Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the… Class IIFDA’s classFeb 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Illinois and North Carolina named
- Medical device recall T:slim Insulin Delivery System Insulin Infusion Pump Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Malibu Polyaxial Screwdriver, 8.0 Plus Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to… Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereArizona, California, Florida, Iowa, Illinois, Louisiana, Maryland, North Carolina, New Mexico, Texas and Virginia
- Medical device recall ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic… RTI Surgical, Inc. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems… The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC). Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry… Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that… Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM… Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that… Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5” x 96” Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5” x 96” Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5” x 96” Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5” x 98” Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vital CARE(TM) REPS INC Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica… Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereIllinois, Massachusetts, Minnesota, North Dakota, Oregon and Pennsylvania
- Medical device recall D-10 Dual Program, which contains Update Kit D-10 A1c program diskette D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual… Class IIIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Normative Data Template CD for use with the I-Portal devices The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k)… Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BrainLAB’s VectorVision spine is intended for use as an intraoperative image-guided localization system for… Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect… Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Minnesota, North Carolina, New York, Ohio and Texas
- Medical device recall VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage:… Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry… Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific, 2.5mm Coyote” OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210 Boston Scientific is initiating this Recall Removal of one lot of the Coyote” OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote”… Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Illinois, Indiana, Michigan, Missouri, New York, Ohio, Pennsylvania and Texas
- Medical device recall Boston Scientific, Coyote” MONORAIL” PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue #… Boston Scientific is initiating this Recall Removal of one lot of the Coyote” OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote”… Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Illinois, Indiana, Michigan, Missouri, New York, Ohio, Pennsylvania and Texas
- Medical device recall 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use No endotoxin (LAL) testing to proper level. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereConnecticut, Florida, Illinois, New Jersey, New York, Pennsylvania, Tennessee, Virginia and Wisconsin
- Medical device recall Stryker CMF Customized Implant Kit X-Large Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedFeb 19, 2014ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Horizon Medical Imaging, Picture Archive Communication System (PACS). Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval… Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm. Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereFlorida, Michigan, Minnesota, Missouri, New Jersey, Ohio and Texas
- Medical device recall GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). Class IIFDA’s classFeb 19, 2014in FDA’s Enforcement Report21 statesnamed in where it went PublishedFeb 19, 2014ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Florida, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Vermont and Wisconsin
- Medical device recall Neptune 2 Rover Ultra Waste Management System. The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neptune 2 Rover Ultra Waste Management System The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ABX PENTRA N Control Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Advanced Energy Aquamantys3 Pump Generator The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Illinois, Kansas, Louisiana, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereColorado, Florida, Georgia, Maine, New York, Ohio, Texas and Virginia
- Medical device recall Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product Name Medtronic, Inc. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use… Manufactured with an incorrect factory set unit of measure. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medical device recall MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use… Manufactured with an incorrect factory set unit of measure. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medical device recall GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Guam named
- Medical device recall Giraffe¿ Infant Warmers Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Panda iRes¿ Infant Warmers Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Stand-Alone Resuscitation Unit, Bag and Mask Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Stand-Alone Resuscitation, T-Piece Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Upgrade Kit, Resuscitation, T-Piece Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart… Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMPAX RIS QDOC 5.8 Patient name displayed (printed) on the Patient Report was the wrong patient name. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Maine, Ohio, Oregon, South Carolina, South Dakota and Texas
- Medical device recall Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Bicarbonate Jug Adapter distributed prior to 510(k) approval Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local… Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportMissourithe one state its words name PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereMissouri
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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