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 Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Ultra-Fine Pen Needles 32G x 4mm Product shelf cartons incorrectly labeled as products intended for the Latin American market. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01… Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kansas, New Jersey, New York and Tennessee
- Medical device recall ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Pennsylvania and Washington named
- Medical device recall REF MC330209 6’ Incorrect filter assemblies in IV administration set. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Massachusetts, Minnesota, New York and Wisconsin named
- Medical device recall Luminesse ML PMMA, 98x20mm Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. Class IIIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 9, 2020ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Oregon and Pennsylvania named
- Medical device recall The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely… The firm has become aware of nine reports by a single customer that the software made false positive calls. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Indiana, New York, Ohio and Pennsylvania named
- Medical device recall Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring… Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Northern Mariana Islands named
- Medical device recall Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 -… The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, “Temperature… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for… Missing solder battery connection, which could interrupt power of insulin pump. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Maryland named
- Medical device recall MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage:… Missing solder battery connection, which could interrupt power of insulin pump. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Maryland named
- Medical device recall MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752 Missing solder battery connection, which could interrupt power of insulin pump. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Maryland named
- Medical device recall MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Product may be missing toric axis marks. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Michigan, Minnesota, Missouri, New Hampshire, Ohio, Tennessee, Texas, Utah and Washington named
- Medical device recall Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the… Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The… Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 9, 2020ClassClass IIStatusCompletedWhereNationwide, and North Carolina and New York named
- Medical device recall MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a… Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 9, 2020ClassClass IIStatusCompletedWhereNationwide, and North Carolina and New York named
- Medical device recall MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a… Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 9, 2020ClassClass IIStatusCompletedWhereNationwide, and North Carolina and New York named
- Medical device recall Regard - Product Usage: Obstetric Gynecologic specialized manual instrument Labeling error, incorrect expiration date. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Missouri and Oklahoma named
- Medical device recall CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or… Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, Nebraska, Nevada, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring… Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, Nebraska, Nevada, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous… Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, Nebraska, Nevada, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous… Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, Nebraska, Nevada, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids… Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, Nebraska, Nevada, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or… Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, Nebraska, Nevada, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall BladderScan Prime Plus Probe Due to a change in handle material and process, probe handle may crack. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin, West Virginia and Wyoming named
- Medical device recall CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Idaho, Louisiana, Minnesota, New Hampshire, Pennsylvania, Wisconsin and West Virginia named
- Medical device recall PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall iTotal Hip Replacement System Incorrect hip components were provided in kits. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Verigene Processor SP Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from… Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Verigene Processor SP Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from… Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RayStation standalone software treatment planning system If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference… Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EMPOWR Partial Knee Peg Drill Guide There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 2, 2020ClassClass IIStatusOngoingWhereArizona, California, Florida, Georgia, Illinois, Indiana, Michigan, Minnesota, New York, Texas, Virginia and Washington
- Medical device recall EMPOWR Partial Knee Peg Drill There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 2, 2020ClassClass IIStatusOngoingWhereArizona, California, Florida, Georgia, Illinois, Indiana, Michigan, Minnesota, New York, Texas, Virginia and Washington
- Medical device recall ViewRay MRIdian System There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Michigan, Missouri, New York, Oregon and Wisconsin named
- Medical device recall ViewRay MRIdian Linac System There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Michigan, Missouri, New York, Oregon and Wisconsin named
- Medical device recall Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor Under certain conditions, there is a risk for fire. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Delaware, Florida, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Texas, Utah, Virginia, Vermont and Wisconsin named
- Medical device recall MEVION S250i, MEVION S250 Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Florida, Missouri, New Jersey and Oklahoma named
- Medical device recall AB PowerCel 230 (velvet black) Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. Class IIIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 2, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Mississippi, Nebraska, New York, Ohio and South Carolina named
- Medical device recall AB PowerCel 170 (velvet black) Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. Class IIIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 2, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Mississippi, Nebraska, New York, Ohio and South Carolina 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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