Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories Generators may have a faulty component which could impact the proper functioning of the device. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to… Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008 Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010 Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium… Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in… Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Celerity ECG Cable Accessory Pack, STERILE The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report19 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, North Carolina, New Jersey, Nevada, Ohio, Oregon, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall Carestream DRX-Revolution Mobile X-Ray System The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Empowr PS Knee Tibial Insert The Empowr PS Insert was reported as missing the impaction slot feature. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida and New York named
- Medical device recall Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for… Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the… Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic… Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the… Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Eye Station Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, North Dakota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Virginia, Washington and West Virginia named
- Medical device recall LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Georgia, New York, Puerto Rico and South Carolina named
- Medical device recall LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Georgia, New York, Puerto Rico and South Carolina named
- Medical device recall HOTLINE Blood and Fluid Warmer, Mole l HL-90 HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling. Class IIIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 15, 2017ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AtriClip” LAA Exclusion System with preloaded Gillinov-Cosgrove” Clip - A single PRO2 device is A complaint of the PRO2 jaw breaking prior to surgery being performed. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report31 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont and Wisconsin
- Medical device recall QUINTUBE Monitor Pack An incorrect sterility status on the label, non-sterile products labeled as sterile Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile)… An incorrect sterility status on the label, non-sterile products labeled as sterile Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InterFuse Tail Traction Tool Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereFlorida, Illinois, Indiana, Maryland, Minnesota, Montana, New York, Ohio, Tennessee, Texas and Wisconsin
- Medical device recall Merge PACS software Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report17 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Hawaii, Illinois, Massachusetts, Maryland, Michigan, Missouri, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Utah and Wisconsin
- Medical device recall Sheridan/CF, Cuffed Tracheal Tube Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall Boston Scientific, EMBLEM S-ICD Programmer There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to… Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 15, 2017ClassClass 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, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total… There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge RadSuite software The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereAlabama, Indiana, Michigan, Pennsylvania and Wisconsin
- Medical device recall VITROS Chemistry Products FS Calibrator 1 The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461… Class IIIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Bariatric Bed - BAR600IVC The junction box used in the bariatric bed may emit sparks and result in a fire. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Bariatric Bed - BARPKG-IVC 1633 A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Foot Section - BAR5490IVC A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Junction Box - 1104343 and 1193560 A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer It was discovered under rare circumstances the LED warning light circuit could fail. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement Report22 statesnamed in where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia and Washington
- Medical device recall Genetic Screening Processor (GSP) The firm became aware that the ball bushing axels are defective in the GSP instrument. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereAlabama, Massachusetts, South Carolina and Texas
- Medical device recall Spare Disk Remover Module The firm became aware that the ball bushing axels are defective in the GSP instrument. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereAlabama, Massachusetts, South Carolina and Texas
- Medical device recall Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures. Lack of sterility assurance Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile Organ preservation fluid recalled due to potential for bacterial contamination. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SwishTapered Implant The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect… Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereCalifornia, Maine, New Mexico, Ohio, Oregon and Texas
- Medical device recall Cannulated Drill bit 2.0mm and 2.6 mm The product is being recalled due to incidence and reports of the product breaking during surgery. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee… labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereCalifornia, Louisiana, Massachusetts, Maryland, New Jersey, Texas, Washington and Wisconsin
- Medical device recall Vanguard Total Knee System Vanguard Open Box Femoral Components packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.plaza, picture archiving and communications system. Software update for improvements and to resolve several issues Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room… Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration… Software error Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE/IMMULITE 1000 Systems, Third Generation PSA Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE/IMMULITE 1000 Systems, Third Generation PSA Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies… Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and New Jersey and Oklahoma named
- Medical device recall Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for… There is the possibility that the radial stem may loosen post-operatively at the stem bone interface. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass 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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