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 5, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used… There is a potential software error during programming. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the… There is a potential software error during programming. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PryTime Medical - ER-Reboa Plus Catheter There is a potential that catheters may have incorrectly marked balloon and arterial lines. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Utah named
- Medical device recall APEX Compounding System Control Panel Module There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the… Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall APEX Compounding System Control Panel Module There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the… Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall APEX Compounding System Control Panel Module There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the… Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility… Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the… Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the… Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee… Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of… Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of… Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tempus LS - Manual Defibrillator A software error was detected within software version 1.3.4 for the Tempus LS device. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Microsurgical Operating Room Tables;7300B Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereArizona, California, Florida, Missouri, North Carolina, Ohio, Pennsylvania, Texas and Wisconsin
- Medical device recall Microsurgical Operating Room Tables;7300BX Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereArizona, California, Florida, Missouri, North Carolina, Ohio, Pennsylvania, Texas and Wisconsin
- Medical device recall Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Massachusetts, North Carolina, New Jersey, Ohio, Pennsylvania, Puerto Rico and Utah
- Medical device recall DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral… Due to footswitch not meeting required specification for protection from ingress of solids or liquids. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Illinois, Indiana, Kentucky, Louisiana, Maryland, North Carolina, Nevada, New York, Oklahoma, Oregon, Texas and Washington
- Medical device recall Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:… RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD PrecisionGlide Needle 30G x 1/2 BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2” Lot No. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Kentucky, Missouri, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee and Virginia named
- Medical device recall RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service… Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InSure ONE Test Strips Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing… Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for… A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Carl Zeiss Meditec Ag VISULENS 550 Due to the incorrect DC/DC converter being assembled onto the communication board. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall Carl Zeiss Meditec AG VISUREF150 Due to the incorrect DC/DC converter being assembled onto the communication board. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall RevMedX Trauma Dressings are RevMedX Trauma Dressing is being recalled due to package seal integrity. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.0mm Cannulated Screw System, BCS Cannulated Screw System Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Reverse Shoulder System Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.