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 6, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012* Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Idaho, Minnesota, Ohio, Texas and Utah named
- Medical device recall CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each B. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Sensis, Computer, Diagnostic, Programmable An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UniCel DxH 800 Coulter Cellular Analysis System There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may… Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall UniCel DxH 600 Coulter Cellular Analysis System There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may… Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the… Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Maryland and Vermont named
- Medical device recall CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR Firm is initiating voluntary correction of CORFLO PEG with ENFit. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereCalifornia, New Hampshire and Vermont
- Medical device recall CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR Firm is initiating voluntary correction of CORFLO PEG with ENFit. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereCalifornia, New Hampshire and Vermont
- Medical device recall CORFLO PEG Kit, Pull 16FR Firm is initiating voluntary correction of CORFLO PEG with ENFit. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereCalifornia, New Hampshire and Vermont
- Medical device recall SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ziehm Imaging solo FD Mobile Fluoroscopic C-arm During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medical device recall Wingman 35 Crossing Catheter, 65cm ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 24, 2017ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Georgia, Michigan, New Jersey and Ohio named
- Medical device recall Magellan Diagnostics LeadCare Ultra Blood Analyzer LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC Trek RX Coronary Dilatation Catheter Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2017ClassClass IStatusTerminatedWhereNo state named
- Medical device recall NC Traveler RX Coronary Dilatation Catheter Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2017ClassClass IStatusTerminatedWhereNo state named
- Medical device recall NC Tenku RX PTCA Balloon Catheter Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2017ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716,… Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall GIZA Vertebral Body Replacement Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report41 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Biomet Microfixation TraumaOne System Surgical Tray Part of the number on the tray lid differ from the part number on the base. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereAlabama, Missouri and Utah
- Medical device recall Access BR Monitor Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereGeorgia, Guam and Puerto Rico
- Medical device recall Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new… Class IIIFDA’s classMay 24, 2017in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 24, 2017ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Minnesota, Mississippi, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Navitrack System - OS Knee Universal, Stereotaxic instrument Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report16 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Indiana, Kansas, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia and Washington
- Medical device recall enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut… Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report22 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and West Virginia
- Medical device recall Lactate Reagent (LACT 2 x 50) Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 24, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Uric Acid Reagent (URIC 2 x 300) Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 24, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Enzymatic Creatinine Reagent (CR-E 2 x 200) Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 24, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Cholesterol Reagent(CHOL 2 x 300) Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 24, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall HDL Cholesterol Reagent (HDL 2 x 200) Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 24, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Triglycerides Reagent (TG 2 x 300) Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 24, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Salicylate Reagent (SALY 2 x 45) Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 24, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall ADVIA Centaur Systems Insulin Calibrator Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ADVIA Centaur Systems Insulin ReadyPack Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN… Diamond particulates may break off the burr and fall into the surgical site. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN… Diamond particulates may break off the burr and fall into the surgical site. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R;… Diamond particulates may break off the burr and fall into the surgical site. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer The strength of the arm mounting mechanism was insufficient and had to be redesigned. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereArizona, California, Florida, Hawaii, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall VORTRAN Automatic Resuscitator, VARPlus Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida and Mississippi
- Medical device recall VORTRAN Automatic Resuscitator, VARPlus with Extension Kit Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida and Mississippi
- Medical device recall Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and… Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, North Carolina, South Carolina and Wyoming
- Medical device recall ARIES System and ARIES M1 System The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for… False susceptible results Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model… Packaging error. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Proton therapy system -Proteus 235 aka Proteus Plus A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall SoftPort Easy-Load Lens Delivery System Complaints concerning kinked haptics that were occurring during lens delivery. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in… Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose… Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 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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