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 5, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall BD Extension Set SMALLBORE Tubing SmartSite VALVE Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD SmartSite Bag Access Device Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD ADD-ON Burette Set V/NV Needle-Free Valve Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD SmartSite Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD SmartSite Bag Access Device Needle-Free Valve Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Arjo Disposable Repositioning Sling Sling loop straps on device pose a trip hazard. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall ACUSON Juniper Diagnostic Ultrasound System Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic… Due to potential performance issues with software version 3.2.3 and earlier. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall McKesson Lap Sponge, X-Ray Detectable 12”x 12”, 5/pack, Sterile McKesson Part # 16-2112121 Manufacturer issued a recall due to an EO indicator color. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportVirginiathe one state its words name PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall The Allura Xper series is intended for use on human patients to perform: “Vascular, cardiovascular and… Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Idaho, Massachusetts, Michigan, Texas and Virginia named
- Medical device recall The Allura Xper series is intended for use on human patients to perform: “Vascular, cardiovascular and… Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Idaho, Massachusetts, Michigan, Texas and Virginia named
- Medical device recall The Azurion series (within the limits of the used Operation Room table) are intended for use to perform:… Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Idaho, Massachusetts, Michigan, Texas and Virginia named
- Medical device recall Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic HVAD Pump Implant Kits There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function The spreader bar can disconnect from the scale bottom attachment. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement Report11 statesnamed in where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Ohio, Pennsylvania and Washington
- Medical device recall BOND Ready-To-Use Primary Antibody CDX2 (EP25) Product may not perform as specified in IFU. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body… If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 15, 2021ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B,… There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 15, 2021ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall LiquaSonic Ultrasound Gel 250mL Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 15, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 15, 2021ClassClass IStatusTerminatedWhereNo state named
- Medical device recall LiquaSonic Ultrasound Gel 5L Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 15, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 15, 2021ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Pipeline Flex Embolization Device Due to potential push wire fractures in the delivery system during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 15, 2021in FDA’s Enforcement Report49 statesnamed in where it went PublishedSep 15, 2021ClassClass IStatusOngoingWhereAlaska, 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, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall EV3 Pipeline Flex Embolization Device with Flex Shield Technology Due to potential push wire fractures in the delivery system during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 15, 2021in FDA’s Enforcement Report49 statesnamed in where it went PublishedSep 15, 2021ClassClass IStatusOngoingWhereAlaska, 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, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic… When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a… When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a… When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8 Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination… Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial… Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial… Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE Infant/Child defibrillator pads contain incorrect labeling. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized… Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 15, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Louisiana, Michigan, New Jersey, Oklahoma, Tennessee, Texas, Virginia and Washington named
- Medical device recall Nihon Kohden NKV-550 Ventilator Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Louisiana, Massachusetts, New York, Pennsylvania, Utah and Vermont named
- Medical device recall Solero Generator Refurbished US PG Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Solero Generator US PG Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass 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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