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 Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants,… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants,… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… 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 - Product Usage: Indicated for the temporary relief of knee pain. Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition… Class IIIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall OPTILITE IgM Kit There is a potential that users may experience difficulty validating the calibration of the kit. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement Report28 statesnamed in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington and West Virginia
- Medical device recall CombiDiagnost GCF, Software v. 1.0.5 When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Texas, Utah and Virginia named
- Medical device recall CombiDiagnost PCF, Software v. 1.0.5 When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Texas, Utah and Virginia named
- Medical device recall DP-30 Digital Ultrasonic Diagnostic Imaging System The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Maryland, New York, South Carolina and Washington named
- Medical device recall Luminos dRF Max Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Luminos Agile Max Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Uroskop Omnia max Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1 STRATAFIX Spiral PDS Plus Violet 18” The product do not meet certain internal testing specifications. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 1 STRATAFIX” Spiral PDS Plus Violet 36” The product do not meet certain internal testing specifications. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 1 STRATAFIX” Spiral PDS Plus Violet 12” The product do not meet certain internal testing specifications. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Luminos dRF Max A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Luminos Agile Max A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals,… A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARTIS Pheno-Interventional Fluoroscopic X-Ray System Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UST-2265-2 Probe These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement Report8 statesnamed in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Massachusetts, Nevada, Ohio, Texas and West Virginia
- Medical device recall PneumoDart, 14 ga x 3.25in. A defect involving an occluded needle was discovered during a training exercise. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and… There have been reported incidents of a loose reservoir that can no longer be locked into the pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedFeb 19, 2020ClassClass IStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Medtronic MiniMed 670G System with SmartGuard There have been reported incidents of a loose reservoir that can no longer be locked into the pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedFeb 19, 2020ClassClass IStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Medtronic MiniMed 620G Insulin Infusion Pump There have been reported incidents of a loose reservoir that can no longer be locked into the pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedFeb 19, 2020ClassClass IStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712,… There have been reported incidents of a loose reservoir that can no longer be locked into the pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedFeb 19, 2020ClassClass IStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to… It was reported that the user’s low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TandemLife ECLS Procedure Kit - V24/A17 The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, Louisiana, Maine and Pennsylvania named
- Medical device recall VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient’s sample result or a valid calibration… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Louisiana, Massachusetts, Michigan, New York and Texas named
- Medical device recall Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Louisiana, Massachusetts, Michigan, New York and Texas named
- Medical device recall Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Louisiana, Massachusetts, Michigan, New York and Texas named
- Medical device recall Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Louisiana, Massachusetts, Michigan, New York and Texas named
- Medical device recall HUDSON RCI COMFORT FLO Corrugated Humidification System There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HUDSON RCI COMFORT FLO Humidification System There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VNS Therapy SENTIVA Generator Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm’s quality specifications. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Kansas, Missouri and Utah
- Medical device recall LivaNova Sorin Connect DPIII KOMPL Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Class IIIFDA’s classFeb 19, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIIStatusTerminatedWhereCalifornia and New Jersey
- Medical device recall Prometra Programmable 20mL Pump A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide
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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