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 Prometra II 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
- Medical device recall Prometra II 40mL 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
- Medical device recall US Clinical 20mL Programmable 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
- 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
- Medical device recall Prometra II 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
- Medical device recall SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stratum Lapidus Plate - Small Rt The product contains a different plate than indicated by the package labeling. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report22 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Texas and Washington
- Medical device recall VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips… Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Revanesse Versa, PN40081 Labeling error. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Kansas, Kentucky, Louisiana, North Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Stryker, Omega 4.75 mm Complaints have been received regarding difficulty in removing the driver from the screw. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report19 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Maine, New Jersey, Nevada, New York, Ohio, Texas, Utah and Wisconsin
- Medical device recall Stryker, Omega 4.75 mm Complaints have been received regarding difficulty in removing the driver from the screw. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report19 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Maine, New Jersey, Nevada, New York, Ohio, Texas, Utah and Wisconsin
- Medical device recall Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in… The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded). Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida and Tennessee
- Medical device recall ROSA Brain 3.0 Application-Brain Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ROSA One 3.1 Brain Application Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Respironics V60 Ventilator, Service # 850008 Ventilator touchscreen may become frozen and fail to respond to touch commands. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941,… Ventilator touchscreen may become frozen and fail to respond to touch commands. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a… Ventilator touchscreen may become frozen and fail to respond to touch commands. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Respironics V680 Ventilator, Service # 850011, (OUS Only) Ventilator touchscreen may become frozen and fail to respond to touch commands. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereOhio and Virginia
- Medical device recall Implant Direct, CE 0086 Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report22 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Georgia, Idaho, Illinois, Indiana, Kentucky, Maryland, Missouri, North Dakota, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Utah, Washington, Wisconsin and West Virginia
- Medical device recall cobas infinity core, Material No. 7154003001 Alarm flags that have a “<” symbol in front of them are not displayed on the cobas infinity Validation screen. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report19 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, California, Georgia, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, New Jersey, New York, Oregon, South Carolina and Tennessee
- Medical device recall Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following:… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B… Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 19, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereIowa, Massachusetts, New York, Ohio and Pennsylvania
- Medical device recall FlexTip Plus Combined Spinal Epidural Catheterization Set There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Set There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall TheraCath Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Combined Spinal Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Combined Spinal Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Combined Spinal Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
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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