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 NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TREK Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TRAVELER Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TRAVELER Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TRAVELER Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TRAVELER Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall NC TRAVELER Coronary Dilatation Catheter Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220) Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medical device recall Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple The kits contained recalled surgical gowns. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow Maximal Barrier Drape ASK-00002-1A Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PSI Kit for use with 7 - 7.5 Fr Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow Central Venous Catheterization Kit ASK-04200-UPM Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow EPIDURAL NEEDLE COMPONENT AN-05505 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow EPIDURAL CATHETERIZATION KIT YC-02220 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow EPIDURAL CATHETERIZATION KIT JH-05500 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow EPIDURAL CATHETERIZATION KIT AM-05500 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow EPIDURAL CATHETERIZATION KIT CK-02220 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow SPINAL ANESTHESIA SET ASA-25090-S Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow EPIDURAL NEEDLE KIT SL-05500 Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PICC Set- PR-35052-HPHNM Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr Product lidstock contains the incorrect expiration date for the product Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EDAN Telemetry Transmitter Firm became aware that it distributed 7 units in the U.S. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE… The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement Report51 statesnamed in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereAlaska, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE… The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement Report51 statesnamed in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereAlaska, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm’s previously approved submission to… Class IIIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in… Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming named
- Medical device recall Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic… Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming named
- Medical device recall i-STAT CHEM8+ cartridges (blue), List No. 09P31-25 The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall i-STAT CG4+ cartridge (blue), List No. 03P85-50 The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Potential for the sterile barrier to be compromised. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI Marketed without a 510(k). Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TLC-2000 Therapeutic Medical Laser System Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard Class IIIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Pentax Video Colonoscope Distributed in the USA without an approved 510K Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereMassachusetts and North Carolina
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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