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 MRSASelect, IVD Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MRSASelect II, IVD Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. Class IIFDA’s classJun 12, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 12, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SOLOPATH Balloon Expandable TransFemoral System There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall SOLOPATH Re-Collapsible Access System There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Portico Solo Re-Collapsible Access System There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Horizon Cardiology Hemo users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall McKesson Cardiology Hemo users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M… The products are mislabeled. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, Pennsylvania, South Carolina and West Virginia
- Medical device recall Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use… The products are mislabeled. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, Pennsylvania, South Carolina and West Virginia
- Medical device recall TactiSys Quartz Equipment (with software version 1.7) In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot… Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and Foot Piece due to potentially inadequate… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Alinity i Processing Module, 03R65 01, with the below components Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide, and Oklahoma and Texas named
- Medical device recall Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T-22800 Material: 701049506 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 22701 Material: 701050790 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 4901 Material: 701050839 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8” Material: 701050859 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 15705 Material: 701051122 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-TOP 30300 Material:701052623 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 33500 3/8” ECC PACK Material: 701053752 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 33501 1/4” ECC PACK Material: 701053754 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 33700 ECC 3/8” PACK Material: 701053845 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 33704 ECC 1/4” PACK Material: 701054150 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 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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