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 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is… PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is… PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is… PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is… PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile… It is possible that the packaging of the product can be damaged by the prongs on the tube set. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall AIA-900 Automated Immunoassay Analyzer Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, Nevada, New York, South Carolina and Texas named
- Medical device recall Multi-Track Angiographic Catheter (MMTA) Instructions for Use booklets were not included on the outer pouch Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedDec 5, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Multi-Track Angiographic Catheter (MMTA) Instructions for Use booklets were not included on the outer pouch Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedDec 5, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Medex High Pressure Stopcock used to control the direction of IV fluid flow Certain lots of Medex” High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to… Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotfix 2 software, it is possible for the original… Class IIFDA’s classDec 5, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereFlorida, Minnesota and Pennsylvania
- Medical device recall HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002… Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Discolored powder has confirmed the presence of a foreign substance Class IIIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Discolored powder has confirmed the presence of a foreign substance Class IIIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Discolored powder has confirmed the presence of a foreign substance Class IIIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and… The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 5, 2018ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and… The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 5, 2018ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and… The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 5, 2018ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and… The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 5, 2018ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and… The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 5, 2018ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric… The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 5, 2018ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall DeltaVision OMX SR Imaging System Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER… A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 28, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 28, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Pouches from this lot are not sealed compromising the sterility Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)… Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 28, 2018ClassClass 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 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 AIA-2000 Analyzer There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to… Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Kentucky, Maryland, Ohio, Pennsylvania and Texas named
- Medical device recall VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27 VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Binding Site Human IgM Kit (for SPAPLUS) After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control… Class IIFDA’s classNov 28, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Indiana, Maryland, North Carolina, Nebraska, New Jersey, New York, Pennsylvania, South Dakota, Virginia, Washington and West Virginia
- Medical device recall Insulia Diabetes Management Companion The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereArizona, Michigan, Ohio, Tennessee and Vermont
- Medical device recall Giraffe OmniBed Carestation Potential electric leakage affecting the user. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Giraffe Incubator Carestation Potential electric leakage affecting the user. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Giraffe Warmer Potential electric leakage affecting the user. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Panda iRes Infant Radiant Warmer Potential electric leakage affecting the user. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Panda Freestanding Warmer Potential electric leakage affecting the user. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Panda Wall Mount warmer Potential electric leakage affecting the user. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tosoh AIA-900 immunoassay Analyzer A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereGeorgia and New York
- Medical device recall Ascom Telligence Nurse Call System There is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communicating to the hallway devices connected to it. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement Report21 statesnamed in where it went PublishedNov 28, 2018ClassClass IIStatusOngoingWhereAlabama, California, Colorado, Georgia, Indiana, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Mississippi, Nebraska, Nevada, Ohio, Pennsylvania, Rhode Island, Texas, Utah, Virginia and Wisconsin
- Medical device recall PremierPro Aluminum Adjustable Walker This recall is due to a mandated order from the FDA for stock recovery and return of the imported item. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNew York, Ohio, Pennsylvania and Texas
- Medical device recall Sedecal NOVA FA DR System A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 28, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model:… In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have increased concentration times of greater than the specification of… Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement Report37 statesnamed in where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall BD Vacutainer Urine Collection Cups BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall BD Vacutainer Specimen Collection Cups BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall KIT URIN CUP PLC 16X100 10.0 UA YEL BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall KIT URIN CUP 16X100 8.0 CONI UA YEL BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class IIFDA’s classNov 28, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereArkansas, Minnesota, Missouri, New Jersey, New York, Ohio and Virginia
- Medical device recall Vanguard Knee System -PS Open Box Femoral Right, 65 mm Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class IIFDA’s classNov 28, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereArkansas, Minnesota, Missouri, New Jersey, New York, Ohio and Virginia
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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