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 Coulter PrepPlus When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Coulter PrepPlus 2 When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Cotton tip of the device may disengage due to insufficient adhesive Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioGlue Surgical Adhesive The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LEGION(R) FEM CONE IMPACTOR HEADS: a) The incorrect Loctite adhesive was used to assemble the impactor heads. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall LEGION(R) TIB CONE IMPACTOR HEADS: a) The incorrect Loctite adhesive was used to assemble the impactor heads. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96… ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereAlabama, Massachusetts, Michigan, Minnesota, Pennsylvania, Texas and Washington
- Medical device recall DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a… FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. Class IIIFDA’s classJul 5, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 5, 2017ClassClass IIIStatusTerminatedWhereMinnesota, Nebraska, Pennsylvania and Texas
- Medical device recall Merge LIS software There are potential issues with results reporting for certain run-based tests. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for… Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a… da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, New York, Ohio and Texas named
- Medical device recall Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5… Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is… Class IIIFDA’s classJul 5, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 5, 2017ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Hawaii, Maryland, Mississippi, New Jersey, Nevada, Oklahoma and Pennsylvania
- Medical device recall 3M Ranger(TM) Pressure Infusor It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing… Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereTexas
- Medical device recall MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology… Retention of Outdated Information in an Order Set. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing,… Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Access Total T3, A34435H The Access immunoassays are susceptible to biotin interference. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereGeorgia, Guam and Puerto Rico
- Medical device recall Access Thyroglobulin, A34085G The Access immunoassays are susceptible to biotin interference. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereGeorgia, Guam and Puerto Rico
- Medical device recall Access System-Free T4 Assay, B01902E The Access immunoassays are susceptible to biotin interference. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereGeorgia, Guam and Puerto Rico
- Medical device recall Access System-GI Monitor (CA19-9), A83873D The Access immunoassays are susceptible to biotin interference. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereGeorgia, Guam and Puerto Rico
- Medical device recall DeRoyal(R) Dolphin Inflation Device Lack of sterility assurance. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Maryland and New York named
- Medical device recall SpO2 connecting cable for Masimo LNCS sensor (Merge Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in… Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Masimo SPO2 Sensor, ear clip-adult (Merge Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in… Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in… Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in… Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Exactech 1.5” Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip… The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to… Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE… The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class IIFDA’s classJul 5, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereArizona, Illinois and Kansas
- Medical device recall ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE… The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class IIFDA’s classJul 5, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereArizona, Illinois and Kansas
- Medical device recall ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE… The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class IIFDA’s classJul 5, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereArizona, Illinois and Kansas
- Medical device recall The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit Incorrect control range in product labeling Class IIIFDA’s classJul 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 5, 2017ClassClass IIIStatusTerminatedWhereArkansas and Florida
- Medical device recall Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer… Linear performance information in product insert does not match that listed in the approved premarket notification Class IIIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DRX-Revolution Mobile X-Ray System Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI)… A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings… Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Wisconsin named
- Medical device recall SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall SHIMADZU RADspeed Pro Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall SHIMADZU FDR Visionary Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Class IIFDA’s classJul 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJul 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Venture RX Catheter Vascular Solutions, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJun 28, 2017ClassClass IStatusTerminatedWhereNationwide, and Alaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Proteus 235 It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereFlorida, Illinois, Louisiana, Massachusetts, New Jersey, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Merge OrthoPACS software Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MiniMed 620G Insulin Infusion Pump Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MiniMed 630G Insulin Infusion Pump Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MiniMed 640G Insulin Infusion Pump Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MiniMed 670G Insulin Infusion Pump Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dimension Troponin 1 (TNI) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Digoxin (DIGXN) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Estradiol (E2) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Ferritin (FERR) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Prolactin (PRL) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 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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