Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and… Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440… The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereGeorgia and New York
- Medical device recall GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may… Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may… Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Codan Filter (Codan Bayer has received reports of loose particulate in the filter when the dust cap is removed. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Colpo-Pneumo Occluder, Part CPO-6 The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement Report51 statesnamed in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a… Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the… Class IIFDA’s classOct 17, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Indiana, Louisiana, Minnesota, Pennsylvania, Puerto Rico, South Carolina, Texas and Virginia
- Medical device recall Journey BCS Knee CoCr Femoral Components The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall JOURNEY BCS OXINIUM Knee Femoral Components The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115,… The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and… Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended… Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall ENDOLOGIX AFX Endovascular AAA System, Stent Graft System Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 10, 2018in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 10, 2018ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 10, 2018in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 10, 2018ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 10, 2018in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 10, 2018ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 10, 2018in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 10, 2018ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ABL90 FLEX analyzers with software versions 3.3MR1 or below The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use Sterility failure found in one of the units in the lot. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Equinoxe Reverse Drill Bit Kit The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 10, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 Potential for product sterility breach due to a compromised or pinched seal defect Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd Potential for product sterility breach due to a compromised or pinched seal defect Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd Potential for product sterility breach due to a compromised or pinched seal defect Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 Potential for product sterility breach due to a compromised or pinched seal defect Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd Potential for product sterility breach due to a compromised or pinched seal defect Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd Potential for product sterility breach due to a compromised or pinched seal defect Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples… Product was assembled with an isolating fiberglass hose within the oven in the wrong position. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall CAPNOSTREAM 20 (US) N The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (US) N The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (US) N - ROHS The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (US) N - ROHS The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20 (US) N W/PRINTER The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (US) N W/PRINTER - ROHS The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (US) N W/PRINTER The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (US) N W/PRINTER - ROHS The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Capnostream20 (US) M The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Capnostream20 (US) M W/PRINTER The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Capnostream20 (US) M TO MASIMO The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Capnostream20 (US) M W/PRINTER TO MASIMO The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Capnostream20 (US) N REFURBISHED The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Capnostream20 (US)M REFURBISHED The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Capnostream20 (US) N W/PRINTER REFURBISHED The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Capnostream20 (US) M W/PRINTER REFURBISHED The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20 (INTL) N The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (INTL) N The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (INTL) N - ROHS The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (INTL) N - ROHS The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20 (INTL) N W/PRINTER The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CAPNOSTREAM 20P (INTL) N W/PRINTER The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
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.”
Your shortlist0 of 4
Add one more to compare.