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 6, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16… Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right… Inability for the guidewire to pass through the needles included with the catheter kits. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Texas, Utah, Virginia and Washington
- Medical device recall Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right… Inability for the guidewire to pass through the needles included with the catheter kits. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Texas, Utah, Virginia and Washington
- Medical device recall Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right… Inability for the guidewire to pass through the needles included with the catheter kits. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Texas, Utah, Virginia and Washington
- Medical device recall Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right… Inability for the guidewire to pass through the needles included with the catheter kits. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Texas, Utah, Virginia and Washington
- Medical device recall Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right… Inability for the guidewire to pass through the needles included with the catheter kits. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Texas, Utah, Virginia and Washington
- Medical device recall Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right… Inability for the guidewire to pass through the needles included with the catheter kits. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Texas, Utah, Virginia and Washington
- Medical device recall Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right… Inability for the guidewire to pass through the needles included with the catheter kits. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Texas, Utah, Virginia and Washington
- Medical device recall Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 20, 2020ClassClass IIStatusOngoingWhereNationwide, and Illinois, Indiana, Missouri and Tennessee named
- Medical device recall Ra Medical Systems DABRA Catheter 5F The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Sterile Oxymetry Oligon Catheter Kit Sterile catheter kit packaging compromised. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report15 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Missouri, South Carolina, Tennessee, Texas and Virginia
- Medical device recall System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the… It was determined that in rare cases persons can receive low dose of unintended radiation. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the… It was determined that in rare cases persons can receive low dose of unintended radiation. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 0.035”(.89mm)x80 cm guidewire The stiffness of the soft end of the guidewire caused tissue perforation. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 13, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall 0.035”(.89mm)x150 cm guidewire The stiffness of the soft end of the guidewire caused tissue perforation. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 13, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max… Restorations crack during the sintering process. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max… Restorations crack during the sintering process. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max… Restorations crack during the sintering process. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max… Restorations crack during the sintering process. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transducer S7-3t UDI The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transducer S7-3t UDI The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transducer S8-3t UDI The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transducer S8-3t UDI The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fukushima suction tubes There was incorrect raw material used in the production of the identified lot. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named
- Medical device recall Python Embolectomy Catheters, Sterile EO, CE The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Bard Embolectomy Catheter & 1 ml SYRINGE The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall R-F Injector Cannula. 18gx10cm-STERILE Incorrect expiration date on introduction cannula packaging. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas, Washington and Wyoming named
- Medical device recall R-F Injector Cannula. 20gx10cm-STERILE Incorrect expiration date on introduction cannula packaging. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Maryland, Michigan, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas, Washington and Wyoming named
- Medical device recall NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant) The top label of article no. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the… Packages of abutments may contain an incorrect screw. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous… Packages of abutments may contain an incorrect screw. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous… Packages of abutments may contain an incorrect screw. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Snappy Abutment 5.5 CC RP 3 mm Packages of abutments may contain an incorrect screw. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Universal Base CC RP 1.5 mm Packages of abutments (universal base) may contain an incorrect screw. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Temporary Snap Abutment Engaging CC RP 1.5 mm Packages of abutments may contain an incorrect screw. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Chest Support for R82 Mustang The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool. Class IIFDA’s classMay 13, 2020in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 13, 2020ClassClass IIStatusTerminatedWhereNorth 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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