Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228 Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Revolution CT GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Potential for a false-negative result. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Vermont named
- Medical device recall Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Potential for a false-negative result. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Vermont named
- Medical device recall Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Potential for a false-negative result. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Vermont named
- Medical device recall Verigene Enteric Pathogens Nucleic Acid Test (EP) Potential for a false-negative result. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Vermont named
- Medical device recall Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Potential for a false-negative result. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Vermont named
- Medical device recall Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Potential for a false-negative result. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Vermont named
- Medical device recall ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. Class IIIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Randox RX Imola Analyser with ISE An issue was identified where the software froze during processing of commands, which resulted in no results displayed. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical… ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Massachusetts, Maryland, Michigan, Minnesota, New York, Ohio, Pennsylvania and Texas named
- Medical device recall The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray… When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray… When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray… When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018 Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportKentuckythe one state its words name PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereKentucky
- Medical device recall Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN… Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN… Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN… Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional… Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for… The high and low level “Quality Controls” demonstrate a positive bias of approximately 10% compared to assigned values. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, District of Columbia, Florida, Georgia, Hawaii, Idaho, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, Texas and Washington named
- Medical device recall Sterile Femoral Angiography Drape with Single Pouch The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nonsterile Femoral Angiography Drape with Single Pouch The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sterile Radial/Femoral Angiography Drape The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nonsterile Radial/Femoral Angiography Drape The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sterile Femoral Angiography Drape The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nonsterile Femoral Angiography Drape The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products… Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FilmArray Pneumonia Panel (Pneumo) Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereAlaska, Alabama, 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, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall FilmArray Pneumonia Panel plus (Pneumoplus) Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereAlaska, Alabama, 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, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CoreValve Evolut R Delivery Catheter System Due to reports of actuator separation for various delivery catheter systems. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement Report48 statesnamed in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall CoreValve Evolut PRO Delivery Catheter System Due to reports of actuator separation for various delivery catheter systems. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement Report48 statesnamed in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall CoreValve Evolut PRO PLUS Delivery Catheter System Due to reports of actuator separation for various delivery catheter systems. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement Report48 statesnamed in where it went PublishedJul 14, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Revolution EVO, Optima CT660, Optima CT680 CT Systems. Improperly loaded software options may result in additional X -ray radiation exposure to the patient. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 7, 2021ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, District of Columbia, Florida, Idaho, Indiana, Massachusetts, Michigan, Missouri, New Mexico, New York, Ohio, South Carolina, Tennessee, Texas and Washington named
- Medical device recall LeadCare II Blood Lead Test Kit Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 7, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeadCare Plus Blood Lead Test Kit Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 7, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LeadCare Ultra Blood Lead Test Kit Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 7, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Synaptive Trackable Suction Set Standard and Malleable Due to visible burrs/metal filings affixed along the suction tube inner perimeter. Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereCalifornia, Florida, Indiana, Louisiana, Maryland, Michigan, North Carolina, Nevada, New York, Oregon, Pennsylvania, South Carolina, Texas, Virginia and Wisconsin
- Medical device recall Edwards TruWave There is a potential that the pressure tubing may detach from the blood sampling system Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Edwards TruWave There is a potential that the pressure tubing may detach from the blood sampling system Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Edwards TruWave x 2 There is a potential that the pressure tubing may detach from the blood sampling system Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520 There is a potential that the pressure tubing may detach from the blood sampling system Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Edwards VAMP Jr. 6 in There is a potential that the pressure tubing may detach from the blood sampling system Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Edwards TruWave There is a potential that the pressure tubing may detach from the blood sampling system Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Edwards TruWave 3 cc/VAMP Jr Kit There is a potential that the pressure tubing may detach from the blood sampling system Class IIFDA’s classJul 7, 2021in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
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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