Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation… A leak may allow for microbial contamination of the sterile fluid path. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is… CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Hemofiltration Standard Pack including BC 60 Plus-T 8036 55 kits were distributed after their expiration date of September 2015. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois and New Mexico
- Medical device recall Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tosoh¿Sorter 9tray This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400 The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400 The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4)… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, Texas and Wisconsin named
- Medical device recall Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module),… Pre-procedural issues related to software defects Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Georgia, Illinois, Missouri, New Mexico, Oklahoma, Oregon, South Carolina and Texas named
- Medical device recall Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer… A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number:… A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G The protective shield was retracted, and the blade was exposed. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o The protective shield was retracted, and the blade was exposed. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bvi Beaver Xstar Safety Slit Knife: (a) The protective shield was retracted, and the blade was exposed. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up The protective shield was retracted, and the blade was exposed. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o The protective shield was retracted, and the blade was exposed. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall BD MAXTM Vaginal Panel BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel,… Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BD MAX” UVE Specimen Collection Kit BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel,… Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BD MAX” CT/GC/TV BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel,… Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Measurement Specialties Reusable Temperature Probe Autoclavable The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJan 31, 2018ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Illinois, Kansas, Kentucky, Minnesota, New York, Ohio, Texas, Virginia and Wisconsin named
- Medical device recall smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating… Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa Class IIFDA’s classJan 31, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereGeorgia, Michigan and Ohio
- Medical device recall smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating… Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa Class IIFDA’s classJan 31, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereGeorgia, Michigan and Ohio
- Medical device recall OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during… This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MyCareLink Patient Monitors Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely… Class IIFDA’s classJan 31, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida and Georgia
- Medical device recall MyCareLink Smart Patient Monitors Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely… Class IIFDA’s classJan 31, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida and Georgia
- Medical device recall CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended… Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance iCT SP Numerous software issues with Brilliance iCT 4.1.6 version. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT Numerous software issues with Brilliance iCT 4.1.6 version. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall daVinci X EndoWrist(R) Stapler 45 Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended… Siemens is releasing a letter to inform about potential data loss relevant to diagnosis. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall Radial Osteotome Blade The expiration date provided on the label is incorrect. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNew Jersey and Tennessee
- Medical device recall PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for… Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Smith & Nephew Taylor Spatial Frame Website software In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081 There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNew York
- Medical device recall MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO Baxter has received customer complaints regarding leakage in the albumin circuit. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNo state named
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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