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 7, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall AquaBeam Handpiece, Sterile EO Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Michigan, Pennsylvania, Texas and Virginia named
- Medical device recall Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures Mislabeled. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall syngo.via syngo.CT Cardiac Function There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall syngo.via syngo.CT Cardiac Planning There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Vygon DUALSTOP Red Cap used for intravascular lines DualStop Caps defect causing leaks in affected product Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vyon DUALSTOP White Cap used for intravascular lines DualStop Caps defect causing leaks in affected product Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter The product lidstock contains a labelling error. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereFlorida and North Carolina
- Medical device recall Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter The product lidstock contains a labelling error. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereFlorida and North Carolina
- Medical device recall Gravity IV Set with 3-port Closed Stopcock Manifold The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Florida, Louisiana, Maryland, Nebraska, Tennessee, Virginia and Washington
- Medical device recall Gravity IV Set with 3-port Closed Stopcock Manifold The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Florida, Louisiana, Maryland, Nebraska, Tennessee, Virginia and Washington
- Medical device recall BD Blood Collection Assembly with Male Luer Lock The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereFlorida and New Jersey
- Medical device recall Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Maine, Michigan, Minnesota, Missouri, Mississippi, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah and Washington
- Medical device recall COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws… Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereArizona, Illinois, Louisiana, Michigan, Missouri, Nevada, Ohio, Pennsylvania, Tennessee and Texas
- Medical device recall CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro There is the potential for debris/material to be found behind the O-rings in the neck trials. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro There is the potential for debris/material to be found behind the O-rings in the neck trials. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro There is the potential for debris/material to be found behind the O-rings in the neck trials. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Azurion FlexArm, 722079 During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportFloridathe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6… One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete… Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall e500 Automatic Transport Ventilator There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 10, 2019ClassClass IStatusTerminatedWhereArizona, California, Colorado, Florida, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall e600 Automatic Transport Ventilator There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 10, 2019ClassClass IStatusTerminatedWhereArizona, California, Colorado, Florida, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall e700 Automatic Transport Ventilator There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 10, 2019ClassClass IStatusTerminatedWhereArizona, California, Colorado, Florida, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall CELL-DYN Emerald analyzer There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Abbott ARCHITECT Creatine Kinase, IVD The product has a stability issue which may lead to an error code indicating “Unable to calculate result, reaction check failure” and/or Quality Control… Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Abbott ARCHITECT Creatine Kinase, IVD The product has a stability issue which may lead to an error code indicating “Unable to calculate result, reaction check failure” and/or Quality Control… Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the… Class IIFDA’s classApr 10, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 10, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, California, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the… When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the… Class IIFDA’s classApr 10, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 10, 2019ClassClass IIStatusOngoingWhereAlaska, Alabama, California, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall iTotal Posterior Stabilized (PS) Knee Replacement System The labeling of the boxes and sterile pouches did not match the contents. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNew Hampshirethe one state its words name PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNew Hampshire
- Medical device recall McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically… Class IIIFDA’s classApr 10, 2019in FDA’s Enforcement Report27 statesnamed in where it went PublishedApr 10, 2019ClassClass IIIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during… Lack of an adequate sterilization validation Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Na¿da CL Q30 Sound Processor, Sand Beige The sound processors were loaded with the incorrect firmware. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Na¿da CI Q70 Sound Processor, Sand Beige The sound processors were loaded with the incorrect firmware. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Na¿da CI Q90 Sound Processor, Silver Gray The sound processors were loaded with the incorrect firmware. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip… Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Micro Knife 5.0mm 30¿ The product contains a misprinted expiration date on the peel pack. Class IIIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 10, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Idaho, Minnesota, Missouri, New York, Ohio, Pennsylvania and Texas named
- Medical device recall Cardiohelp Emergency Drive Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 3, 2019ClassClass IStatusTerminatedWhereNationwide, and California, Florida, Illinois, Kentucky, Michigan and New York named
- Medical device recall Kendall SCD Express Sterile Sleeves (Thigh Length) The product does not meet sterility requirements. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereCalifornia, New Jersey and Washington
- Medical device recall JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereOregon and Tennessee
- Medical device recall JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereOregon and Tennessee
- Medical device recall JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereOregon and Tennessee
- Medical device recall JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class IIFDA’s classApr 3, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereOregon and Tennessee
- Medical device recall Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Breach in the sterile barrier pouch may compromise sterility of the device. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Maryland, Michigan, New Mexico, Ohio and Pennsylvania named
- Medical device recall Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Breach in the sterile barrier pouch may compromise sterility of the device. Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Maryland, Michigan, New Mexico, Ohio and Pennsylvania named
- Medical device recall LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge… The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose… The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose… The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 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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