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 ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access… Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port,… Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide… Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety… The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r)… The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r)… The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Beekley Medical 0-SPOT Mammography Skin Markers Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels Class IIIFDA’s classJun 14, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 14, 2017ClassClass IIIStatusTerminatedWhereArkansas, California, Georgia, Illinois, Minnesota, Nevada, New York, Texas and Wisconsin
- Medical device recall Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open… COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in… COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open… COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 “ Sml amber glass… MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification. Class IIIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes various orthopedic instruments modified by U.S Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Pennsylvania and Virginia named
- Medical device recall Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque… Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nexstim eXima NBS System Software version 2.2 or higher Software defect: the NBS software may accidentally generate duplicate copies of one or several files. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJun 14, 2017ClassClass IIStatusOngoingWhereGeorgia
- Medical device recall NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or… Software defect: the NBS software may accidentally generate duplicate copies of one or several files. Class IIFDA’s classJun 14, 2017in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJun 14, 2017ClassClass IIStatusOngoingWhereGeorgia
- Medical device recall Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument Over-tensioning of the band resulting in damage to the band causing it to rupture Class IIFDA’s classJun 14, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 14, 2017ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Missouri, North Carolina, New York and Ohio
- Medical device recall Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement Report28 statesnamed in where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia) Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 7, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 7, 2017ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Pausch Uroview FD fluoroscopic X-ray system UDI number During patient interventions with the urology table the radiation is activated with a footswitch connected to the table. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems… Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8¿C,… Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic… According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). Class IIIFDA’s classJun 7, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 7, 2017ClassClass IIIStatusTerminatedWherePuerto Rico
- Medical device recall AIA-PACK TPOAb CONTROL SET The label contains two different methodologies. Class IIIFDA’s classJun 7, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 7, 2017ClassClass IIIStatusTerminatedWhereAlaska, Florida, Georgia, Massachusetts, New York, Ohio, Oklahoma and Texas
- Medical device recall AIA-PACK TgAb CONTROL SET The label contains two different methodologies. Class IIIFDA’s classJun 7, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 7, 2017ClassClass IIIStatusTerminatedWhereAlaska, Florida, Georgia, Massachusetts, New York, Ohio, Oklahoma and Texas
- Medical device recall Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M… Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall 1000 ml Canister (with Gel) for InfoV.A.C Potential sterile barrier breach Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Elecsys PreciControl Varia 3 e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH… Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM There is a risk that the pinion gear in the device could fail under extreme use cases. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NMT Patient Cable Manufacturing defect may cause localized heating, which may result in localized skin burn. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement Report31 statesnamed in where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE Recalled by FDA on Jun 7, 2017 Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes… Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes… Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems Reported incidents of a patient step detaching from the table. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Dolphin Inflation Device The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereCalifornia, Hawaii, Louisiana, Nevada, Ohio, Oklahoma, Oregon, Puerto Rico, South Carolina, Tennessee, Texas and Washington
- Medical device recall The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Reusable instruments in the Knee, Hip, Trauma, and Extremities segments. Durability characteristics of reusable instruments were not established Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte… Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall Estrogen Receptor (EP1) 7.0 mL Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall Estrogen Receptor (SP1) 7.0 mL Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro… Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall Her2/Neu (c-erbB-2) (CB-1 1) Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall Her2/Neu (EP3) Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall Herpes Simplex Virus I Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall Herpes Simplex Virus II 0.5 ml Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall SV40 (MRQ-4) 0.5 ml Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas 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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