Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Monoject Standard Hypodermic Needle Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Standard Hypodermic Needle, 16 G x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Standard Hypodermic Needle, 16 G x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Standard Hypodermic Needle, 18 G x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Standard Hypodermic Needle, 27 G x 1-1/4” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Standard Hypodermic Needle, 20 G x 1-1/2” bulk Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject” 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Blunt Cannula, 15 G x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Blunt Cannula, 16 G x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Blunt Cannula, 19 G x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Blunt Cannula, 20 G x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Monoject Blunt Cannula, 22 G x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
- Medical device recall MOOG Curlin Infusion Administration Set Administration sets leaked at the filter. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereGeorgia, Illinois, Kansas, Massachusetts, Michigan and Ohio
- Medical device recall MOOG Curlin Infusion Administration Set Administration sets leaked at the filter. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereGeorgia, Illinois, Kansas, Massachusetts, Michigan and Ohio
- Medical device recall Nimbus Administration Set Potential for tube leakage Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall LEEP Precision Integrated System 120V & LEEP Precision Generator The products’ cut, coagulate, or blend function may not operate with the use of the Foot Pedal. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zyno Medical Administration Set -105”ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion… Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Zyno Medical Administration Set -105”ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion… Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall MAC VU360, Model Number 2030360-001, Electrocardiograph Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Breast Milk Transfer Lid for use with Oral Syringe Connectors The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact. Class IIIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 31, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Illinois, Missouri, Nebraska, Ohio, Rhode Island, Tennessee, Texas and Virginia named
- Medical device recall Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in Mislabeled - The product’s labeling contains an incorrect size for the catheter included in the kit. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Idaho, New York, Oklahoma, Texas and Washington
- Medical device recall Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in Mislabeled - The product’s labeling contains an incorrect size for the catheter included in the kit. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Idaho, New York, Oklahoma, Texas and Washington
- Medical device recall U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower… Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereArizona and Pennsylvania
- Medical device recall PulsioFlex Monitoring System The monitor displays an error message . Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, New York, Oklahoma and South Carolina named
- Medical device recall ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the… Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. Class IIIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJul 31, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and… Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. Class IIIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJul 31, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide, and Alabama, Arizona, Colorado, Connecticut, Florida, Illinois, Kansas, Michigan, Ohio, Pennsylvania, Virginia, Wisconsin and West Virginia named
- Medical device recall GammaPod Stereotactic Radiotherapy System One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereMaryland and Texas
- Medical device recall IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RX Daytona, Model Nos. RX4040 and RX4041 There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Utah and West Virginia
- Medical device recall RX Imola, Model Nos. RX4900 There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Utah and West Virginia
- Medical device recall VITALE Silicon Foam Dressings 4”x4” Adhesive border was not sticky enough. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereOhio, Pennsylvania and Virginia
- Medical device recall Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The… The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedJul 24, 2019ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 24, 2019ClassClass IStatusTerminatedWhereNationwide, and Alabama and Texas named
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use. Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2019ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use. If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2019ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall CS100 Intra-Aortic Balloon Pump, English, 110V If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2019ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall CS100 Intra-Aortic Balloon Pump, English, 220V If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2019ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall CS300 Intra-Aortic Balloon Pump, English, 110V If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2019ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall CS300 Intra-Aortic Balloon Pump, English, 220V If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2019ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray… Additional low dose radiation exposure. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only) Lack of an adequate sterilization validation. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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