Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab… The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous… The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall ADVANTIO DR EL (pacemaker) The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall INGENIO DR EL (pacemakers) The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall VITALIO DR EL (pacemaker) The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall INVIVE CRT-P The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall INLIVEN CRT-P The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medical device recall Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Two lots have been swapped thus have the incorrect product in the package. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereIllinois and Texas
- Medical device recall Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Canon Vantage Titan 3T, Premium Open-Bore MRI System The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Canon Vantage Galan 3T The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120 The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereFlorida, Illinois, Tennessee and Wisconsin
- Medical device recall Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference… The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereFlorida, Illinois, Tennessee and Wisconsin
- Medical device recall EcoFit cup cementless A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida and Texas named
- Medical device recall EASYGRIP FLO-41 US There is a discrepancy in the expiry date encoded into the 2D barcode. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high… GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high… GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high… GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high… GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high… GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA MR380, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Artist, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Voyager, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked… Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box. No 510(k) clearance Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack No 510(k) clearance Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm Marketed without a 510K Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Idaho, Illinois, New York, Ohio and Texas named
- Medical device recall Arrow Temporary Pacing Catheter/Introducer Kit 6Fr Marketed without a 510K Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Idaho, Illinois, New York, Ohio and Texas named
- Medical device recall Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm Marketed without a 510K Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Idaho, Illinois, New York, Ohio and Texas named
- Medical device recall Arrow Temporary Pacing Catheter/Introducer Kit 5Fr Marketed without a 510K Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Idaho, Illinois, New York, Ohio and Texas named
- Medical device recall HeartWare, HVAD Pump Implant Kit The pump has an impeller with a shroud height that did not meet the lower control limit. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0 PC Application Software c4D not changing Site upon synchronization during the Setup workflow step Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Kentucky, Missouri and Washington named
- Medical device recall Medtronic LINQ II Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC’s after a ride-through POR reset. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall BULKAMID, URETHRAL BULKING SYSTEM Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. Mixed Up. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJul 21, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia named
- Medical device recall Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures… The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Florida, Georgia, Indiana, North Carolina, New Jersey and West Virginia named
- Medical device recall HydraVision Digital Imaging System Product ID/Reorder Number: 705559 Failure to comply with the performance standard for fluoroscopy systems. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131 Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231 Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331 Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNo state 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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