Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Babi.Plus 12.5 cm H2O Pressure Relief Manifold Reports of pressure relief manifold venting gas below the standard pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 1, 2020ClassClass IStatusTerminatedWhereNorth Carolina and Nevada
- Medical device recall Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold Reports of pressure relief manifold venting gas below the standard pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 1, 2020ClassClass IStatusTerminatedWhereNorth Carolina and Nevada
- Medical device recall Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port Reports of pressure relief manifold venting gas below the standard pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 1, 2020ClassClass IStatusTerminatedWhereNorth Carolina and Nevada
- Medical device recall VNS Therapy, SenTiva Sentiva generators may reset and become disabled within 60 days of enabling. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJan 1, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 3M Durapore Advanced, Surgical Tape While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Snapshot Tracker Kit, Mas2659-01, KIT0898 The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement Report26 statesnamed in where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, North Dakota, New York, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and West Virginia
- Medical device recall ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic… Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, Tennessee and Texas named
- Medical device recall ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The… Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, Tennessee and Texas named
- Medical device recall BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended… During the firm’s review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire,… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct… When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide… When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric… When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system… Cordis has initiated a labeling correction for S.M.A.R.T. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Cordis Precise Nitinol Stent System Cordis has initiated a labeling correction for S.M.A.R.T. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Cordis S.M.A.R.T Cordis has initiated a labeling correction for S.M.A.R.T. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRA, Drill CS 4.5, quick coupling single use Products were distributed with the incorrect instructions for use. Class IIIFDA’s classJan 1, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 1, 2020ClassClass IIIStatusTerminatedWhereTexas
- Medical device recall INTEGRA, Drill CS 4.0, quick coupling single use Products were distributed with the incorrect instructions for use. Class IIIFDA’s classJan 1, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 1, 2020ClassClass IIIStatusTerminatedWhereTexas
- Medical device recall Lamicel 20PK 3MM INTL Cervical dilator Routine sterilization dose does not meet the required Sterility Assurance Level. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Lamicel 20PK 5MM INTL Routine sterilization dose does not meet the required Sterility Assurance Level. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Lamicel 10PK 10MM INTL Routine sterilization dose does not meet the required Sterility Assurance Level. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall RayStation stand-alone software treatment planning system Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall STA UNICALIBRATOR (ref. 00675) A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement Report42 statesnamed in where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall STA SYSTEM CONROL N + P (ref. 00678) A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement Report42 statesnamed in where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall 7% BSA (Bovine Serum Albumin) Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Urine Electrolyte Diluent Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when… Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus… This lot of test strips is showing an under-recovery when tested against a reference method. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement Report16 statesnamed in where it went PublishedJan 1, 2020ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee and Wisconsin
- Medical device recall Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT There is a potential performance issue as detected by an under-recovery of sample results during routine testing. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 1, 2020ClassClass IIStatusOngoingWhereNationwide, and California and Kentucky named
- Medical device recall Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT There is a potential performance issue as detected by an under-recovery of sample results during routine testing. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 1, 2020ClassClass IIStatusOngoingWhereNationwide, and California and Kentucky named
- Medical device recall Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT There is a potential performance issue as detected by an under-recovery of sample results during routine testing. Class IIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 1, 2020ClassClass IIStatusOngoingWhereNationwide, and California and Kentucky named
- Medical device recall AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. Class IIIFDA’s classJan 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2020ClassClass IIIStatusTerminatedWhereNationwide
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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