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 CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02 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 - ROHS, CS08658-03 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 (INTL) M, CS08654 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 M ADULT ICU (CPM), CS08654RA 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 M NICU (CPM), CS08654RN 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 (INTL) M W/PRINTER, CS08660 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 M W/PRINTER CYVITAL, CS08796 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 N W/PRINTER CYVITAL, CS08798 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 N CYVITAL, CS08799 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 (INTL) N REFURBISHED, CS78652 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 (INTL) M REFURBISHED, CS78654 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 (INTL) N W/PRINTER REFURBISHED, CS78658 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 (INTL) M W/PRINTER REFURBISHED, CS78660 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 (COV-INTL) N W/PRINTER ROHS, CS051COV 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 - ROHS, CS051COV-03 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 VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products - FSH Reagent Pack The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products - Prolactin Reagent Pack The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products - TSH Reagent Pack The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert,… The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. Class IIIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 10, 2018ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Oklahoma, Tennessee and Texas named
- Medical device recall Hemotherm 400CE Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this… These devices have an incorrect specification against safety standard ISO61010-1. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Kansas, Massachusetts, Missouri, New Jersey, Ohio and Wisconsin named
- Medical device recall Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial… Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereColorado, Georgia, Illinois, Maryland and Puerto Rico
- Medical device recall Heart Ware(TM) HVAD(TM) System Controller/Controller Kits Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential… 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 Retrograde Cardioplegia Cannula The device was built with the rigid insertion stylet instead of the flexible stylet. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereSouth Carolina
- Medical device recall ICU Medical 14” Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedOct 10, 2018ClassClass IIStatusCompletedWhereAlabama, California, Florida, Georgia, Illinois, Michigan, Mississippi, North Carolina, New York, Pennsylvania, Utah, Washington and Wisconsin
- Medical device recall EEA Circular Stapler with Tri-Staple Technology The firm identified the potential for a device to have an incorrect tissue gap. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, North Carolina, New York and Utah named
- Medical device recall smiths medical portex First Breath Adult Nasal Cannula “Manufactured” and “Use By” labels are transposed incorrectly suggesting the product expires before it was manufactured. Class IIIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 10, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Oklahoma, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall smiths medical portex First Breath Adult Nasal Cannula “Manufactured” and “Use By” labels are transposed incorrectly suggesting the product expires before it was manufactured. Class IIIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 10, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Oklahoma, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall smiths medical portex First Breath Adult Nasal Cannula “Manufactured” and “Use By” labels are transposed incorrectly suggesting the product expires before it was manufactured. Class IIIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 10, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Oklahoma, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall smiths medical portex First Breath Nasal Oxygen Cannula “Manufactured” and “Use By” labels are transposed incorrectly suggesting the product expires before it was manufactured. Class IIIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 10, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Oklahoma, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall smiths medical portex First Breath Nasal Oxygen Cannula “Manufactured” and “Use By” labels are transposed incorrectly suggesting the product expires before it was manufactured. Class IIIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 10, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Oklahoma, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall VITROS Sodium Slides Potential for positively biased results Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70 The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereColorado, New Jersey, New York, Ohio, Pennsylvania and West Virginia
- Medical device recall C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into… Firm become aware of reports of post-operative refractive errors following implantation of lenses. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Bronchovideoscope BF-160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchofiberscope F-1T160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchovideoscope BF-1T180 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchovidescope BF-1T240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchovideoscope BF-1T60 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchovideoscope F-1TQ180 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchovideoscope BF-240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchovideoscope BF-3C160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchovideoscope BF-3C40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchofiberscope BF-40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchofibercope BF-6C240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchovideoscope BF-MP160F The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass 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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