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 ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated… Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a… Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RadPRO(R) Mobile 40kW Digital X-Ray System There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the… Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20… The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair… Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using… Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 21, 2018ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Expired intraocular lenses were distributed. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Minnesota, North Carolina, Nevada, Texas, Washington and West Virginia named
- Medical device recall Dimension Lipase Flex Reagent Cartridge There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Lipase Flex Reagent Cartridge There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain… Electrophysiology catheters were identified to be item # D134903 and distributed. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportKansasthe one state its words name PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereKansas
- Medical device recall Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia The products labeling contains inconsistencies. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Illinois, Michigan, North Carolina, New Jersey, Pennsylvania and Wisconsin named
- Medical device recall AIA-900 Analyzer Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage:… Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedNov 14, 2018ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips Abnormally high INR test results with the affected CoaguChek test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm Potential for outer pouch sterile barrier to be compromised Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Illinois, Michigan, New Jersey and Ohio named
- Medical device recall Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images… Synchronization failure Class IIFDA’s classNov 14, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Delaware, Florida, Hawaii, New York, Oklahoma, Pennsylvania, South Dakota, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and… Synchronization failure Class IIFDA’s classNov 14, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Delaware, Florida, Hawaii, New York, Oklahoma, Pennsylvania, South Dakota, Texas, Washington, Wisconsin and West Virginia
- Medical device recall ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 Class IIFDA’s classNov 14, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Nevada, New York and Pennsylvania
- Medical device recall Endoform Dermal Template 2x2 Potential for pouch seal failure Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoform Dermal Template 2x2 Potential for pouch seal failure Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoform Dermal Template 4x5 Potential for pouch seal failure Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Liquid Cardiac Control, CQ5051 Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereIndiana, New York, Puerto Rico and West Virginia
- Medical device recall Liquid Cardiac Control, CQ5052 Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereIndiana, New York, Puerto Rico and West Virginia
- Medical device recall Liquid Cardiac Control, CQ5053 Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereIndiana, New York, Puerto Rico and West Virginia
- Medical device recall EZ1 Advanced XL An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, South Dakota, Virginia and Washington named
- Medical device recall BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter) One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk… Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Louisiana, Michigan, North Dakota, Nebraska, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Virginia, Washington and West Virginia named
- Medical device recall Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump… Complaints where users were unable to prime the administration set. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medical device recall PCEA ASV Yellow Microbore The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PCEA Kit ASV Yellow Stripe Microbore The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Pointe Scientific AutoHDL/LDL Cholesterol Calibrator Vials of the autoHDL/LDL Calibrator were shipped without a vial label. Class IIIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 14, 2018ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Michigan and Ohio named
- Medical device recall Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac,… Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test). Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Wisconsin named
- Medical device recall TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve,… During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 14, 2018ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 The reagent pack exhibits the potential for an increased frequency of calibration failures. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile… There is a potential for comingling of the 43MM and 51 MM molds Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Michigan, Ohio, Virginia and Wisconsin named
- Medical device recall Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4” X 5”, 10 Pads, Catalogue number SNS58315 The sterilization process used was unqualified. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4” X 5”, 12 Pads, Catalogue number SNS58345 The sterilization process used was unqualified. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Incorrect package labeling identifying the device Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Incorrect package labeling identifying the device Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS… O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System (“IAS”) product label; replacing… Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU’s) only Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas and Virginia named
- Medical device recall Medtronic CareLink 2090 Programmer Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with… Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 14, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic CareLink Encore 29901 Programmer Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with… Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 14, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CyberKnife M6 A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 14, 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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