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 Endoscopic Curved Intraluminal Stapler, 21 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Endoscopic Curved Intraluminal Stapler, 25 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Endoscopic Curved Intraluminal Stapler, 29 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Endoscopic Curved Intraluminal Stapler, 33 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Straight Intraluminal Staplers, 21 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Straight Intraluminal Staplers, 25 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Straight Intraluminal Staplers, 29 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Straight Intraluminal Staplers, 33 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices Background calibration has the potential to cause false positive or false negative test results. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Background calibration has the potential to cause false positive or false negative test results. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wombat Living, Size 3 Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Abbott Alinity ci-series System Control Module software version 2.5.1 Potential performance issues in the Alinity-ci software version 2.5.1 Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report19 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Georgia, Illinois, Massachusetts, Maine, Minnesota, Missouri, New York, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall SureSigns VS3 NBP, Product Number 863069 System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall SureSigns VS3 NBP Temp, Product Number 863070 System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall SureSigns VS3 NBP, SpO2, Product Number 863071 System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall SureSigns VS3 NBP, SpO2, Rec, Product Number 863072 System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall SureSigns VS3 NBP, SpO2, Temp, Product Number 863073 System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074 System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall SureSigns VS4 NBP, SpO2, Product Number 863283 System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall SureSigns VS4 Government Bundle, Product Number 863286 System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Pentax Medical C2 CryoBalloon Standard Focal Catheter Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely… Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall Pentax Medical C2 CryoBalloon Pear Focal Catheter Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely… Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall Pentax Medical C2 CryoBalloon Standard 90 degree Catheter Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely… Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall CS011 GNR PNA FISH Control Slide May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereConnecticut, Michigan and Virginia
- Medical device recall Fungitell Kit The kits may contain the incorrect number of components or the kits may be missing components. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Maryland, Utah and Virginia named
- Medical device recall Tissu-Trans FILTRON 100 The pouch integrity of the sterile product can’t be assured without a visual examination due to possibly containing a cut or hole in the pouch. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Tissu-Trans FILTRON 250 The pouch integrity of the sterile product can’t be assured without a visual examination due to possibly containing a cut or hole in the pouch. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Tissu-Trans FILTRON 500 The pouch integrity of the sterile product can’t be assured without a visual examination due to possibly containing a cut or hole in the pouch. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Tissu-Trans FILTRON 1000 Recalled by FDA on May 22, 2019 Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Tissu-Trans FILTRON 2000 Recalled by FDA on May 22, 2019 Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Tissu-Trans MEGA 1500 The pouch integrity of the sterile product can’t be assured without a visual examination due to possibly containing a cut or hole in the pouch. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Tissu-Trans Syringe Fill 360 The pouch integrity of the sterile product can’t be assured without a visual examination due to possibly containing a cut or hole in the pouch. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2019ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Terumo Advanced Perfusion System 1 Electronic Patient Gas System The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Flowable Wound Matrix Stability did not meet acceptance criteria for visual appearance during mixing and force vs. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family… In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated… In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of… In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of… In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MediPress pneumatic compression system, Half Leg-Segmental Gradient Product design change did not receive proper premarket clearance and lacks a 510 (k) Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient Product design change did not receive proper premarket clearance and lacks a 510 (k) Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient Product design change did not receive proper premarket clearance and lacks a 510 (k) Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient Product design change did not receive proper premarket clearance and lacks a 510 (k) Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient Product design change did not receive proper premarket clearance and lacks a 510 (k) Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient Product design change did not receive proper premarket clearance and lacks a 510 (k) Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall M200 Fall Monitoring System Damaged capacitor on the printed circuit board. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereConnecticut, Florida, Ohio, Oklahoma, Texas, Washington and West Virginia
- Medical device recall Power-LOAD Cot Fastening System The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Molift 2-Point sling bar, an accessory for Molift Mover 205 The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar… Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusOngoingWhereArizona, Delaware, Florida, Georgia, Massachusetts, Ohio, South Carolina, Texas, Washington and Wisconsin
- Medical device recall Molift 2-Point sling bar, an accessory for Molift Mover 180/Air The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar… Class IIFDA’s classMay 22, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusOngoingWhereArizona, Delaware, Florida, Georgia, Massachusetts, Ohio, South Carolina, Texas, Washington and Wisconsin
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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