Medical devices, 2018
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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 Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are… Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, New York, Texas and Virginia
- Medical device recall St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID;… Inadequate seal due to lack of adhesive glue FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 3, 2018ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Colorado, Florida, Michigan, Ohio, Texas and Washington named
- Medical device recall L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage. L3 has determined in airport environments, there have been several cases where a small air gap has developed where the entrance or exit tunnels meet up with… Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medical device recall VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671 The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Hi-Art(R) System Uncontrolled couch Z-axis movement (descent) Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TomoHD(R) System Uncontrolled couch Z-axis movement (descent) Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TomoH(R) System Uncontrolled couch Z-axis movement (descent) Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TomoHDA(R) System Uncontrolled couch Z-axis movement (descent) Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum The serum may fail to agglutinate within the specified minimum reaction time. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Orthofix Power Drill Torque Limiter, Sterile The power drill torque limiter may break during use in surgery application. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida and Pennsylvania
- Medical device recall IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement… Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 3, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Elastic Esmark Bandage, 3” x 9”, individually Product did not undergo correct sterilization procedures and may potentially be non-sterile. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and Washington 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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