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 Hidrex USA DVP1000 The device was reclassified from a class III device to a class II device and there are new documentation requirements. Class IIIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Daavlin Aquex (DAAV1000) The device was reclassified from a class III device to a class II device and there are new documentation requirements. Class IIIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701 The single use devices are provided sterile and do not have an expiration date on the label. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702 The single use devices are provided sterile and do not have an expiration date on the label. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703 The single use devices are provided sterile and do not have an expiration date on the label. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704 The single use devices are provided sterile and do not have an expiration date on the label. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705 The single use devices are provided sterile and do not have an expiration date on the label. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706 The single use devices are provided sterile and do not have an expiration date on the label. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which… Power outages causes reporting software to shutdown. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Massachusetts, Maine, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, Pennsylvania, South Dakota, Texas, Virginia and West Virginia named
- Medical device recall Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS Eye Station images were not importing properly and were imported under “unknown” due to an issue when validating patients using only an Medical Record Number… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal Heart Tracecart DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current… Class IIIFDA’s classMar 1, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 1, 2017ClassClass IIIStatusTerminatedWhereLouisiana and Mississippi
- Medical device recall SRHS DeRoyal Heart Tracecart DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current… Class IIIFDA’s classMar 1, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 1, 2017ClassClass IIIStatusTerminatedWhereLouisiana and Mississippi
- Medical device recall Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine… Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GrebSet Micro-Introducer Kit Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Iowa, Idaho, Louisiana, Maryland, Maine, Missouri, Mississippi, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Vermont, Washington and Wisconsin named
- Medical device recall Comprehensive Reverse Shoulder System Humeral Tray Higher than anticipated rate of fracturing due to design. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are… The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedFeb 22, 2017ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BrightView XCT The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement Report27 statesnamed in where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Texas, Vermont, Washington and Wisconsin
- Medical device recall BrightView X upgraded to XCT 882454 The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement Report27 statesnamed in where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Texas, Vermont, Washington and Wisconsin
- Medical device recall Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution,… Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Illinois, Minnesota, Missouri, New York, South Carolina, Texas, Wisconsin and West Virginia named
- Medical device recall BD Vacutainer Buffered Sodium Citrate A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an… Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in… On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of… Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Indiana named
- Medical device recall LIMA Modular Revision Hip Stem Lima Proximal Bodies were inadvertently re-sterilized. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Hawaii, Mississippi, New York, Ohio, Oklahoma, Rhode Island and Texas named
- Medical device recall Integra Cadence Total Ankle System Posterior tibial fractures have been reported. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Restoris RIO Reamer Handle, Offset, Mako Failure of the Offset Cup Reamer Handle not engaging its mating components. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone… The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may… Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may… Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may… Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERRAD NX Sterilization System Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be… Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Arthrex Shoulder Suspension Tower During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field… Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportFloridathe one state its words name PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall 6-hole Pubic Symphysis plate (PN 70-0451) The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). 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 VIDAS 3 software v. 1.1.4 During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version… 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 Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve… 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 StarClose SE Vascular Closure System Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedFeb 22, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a… There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and West Virginia named
- Medical device recall Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air… Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air… Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To… Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To… Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air… Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or… Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air… Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the… Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. 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 ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the… Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. 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 ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy… Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. 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 PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS… Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. 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 The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase… Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Class IIIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the… Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Class IIIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
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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