Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Covidien Kendall Adult Multi-Function Defibrillation Electrodes Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MediChoice¿ Multifunction Electrode Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Philips HEARTSTART Multifunction Electrode Pads Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000 Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Omni Micro-electrode/reference electrode for cobas b221 analyzer The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. Class IIIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedOct 22, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, Maryland, North Carolina, New Hampshire, New York, Ohio, Pennsylvania and Wisconsin named
- Medical device recall Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline… The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open… Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AC Powered adjustable bed frame Firm received several complaints that the head deck actuator bracket had separated from the bed frame. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, Mississippi, North Carolina, New Mexico, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall eFilm Workstation 4.0 and 4.0.1 There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple… Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Expression MR200 MRI Patient Monitoring System Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Michigan, New Jersey, Nevada and Texas
- Medical device recall V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection.… A portion of the V.A.C. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ArcPoint Labs 5 Panel Dip Drug Screen Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as… Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportAlabamathe one state its words name PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereAlabama
- Medical device recall ArcPoint Labs 10 Panel Dip Screen (BAR) Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as… Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportAlabamathe one state its words name PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereAlabama
- Medical device recall ArcPoint Labs 10 Panel Dip Screen (OXY) Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as… Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportAlabamathe one state its words name PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereAlabama
- Medical device recall EndoWrist Stapler 45 instrument for the da Vinci Si System Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler… Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement… An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Ohio and South Dakota named
- Medical device recall Multi-Lumen Central Venous Catheterization Kit Arrow International, Inc. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Kentucky, Louisiana, Maryland, North Carolina, Nevada, New York, Ohio and Pennsylvania
- Medical device recall VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System, System Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling… The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the sling. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereArkansas, District of Columbia, Georgia, Michigan and Pennsylvania
- Medical device recall 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis… The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine… The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a… The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek… The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. Class IIFDA’s classOct 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and… Nemschoff Chairs, Inc. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological… The affected lots could have NBF concentrations that are lower or higher than the desired specifications. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 15, 2014ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Richard-Allan Scientific Specimen Transportation System The affected lots could have NBF concentrations that are lower or higher than the desired specifications. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 15, 2014ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Richard-Allan Scientific 10% Neutral Buffered Formalin The affected lots could have NBF concentrations that are lower or higher than the desired specifications. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 15, 2014ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Richard-Allan Scientific Bio-Tite Specimen Containers The affected lots could have NBF concentrations that are lower or higher than the desired specifications. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 15, 2014ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Richard-Allan Scientific 10% Neutral Buffered Formalin The affected lots could have NBF concentrations that are lower or higher than the desired specifications. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 15, 2014ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to… The affected lots could have NBF concentrations that are lower or higher than the desired specifications. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 15, 2014ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Cardinal Health Prefilled Buffered 10% Formalin The affected lots could have NBF concentrations that are lower or higher than the desired specifications. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 15, 2014ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Georgia, Idaho, Illinois, Massachusetts, Maryland, Minnesota, North Carolina, Nebraska, Ohio, Pennsylvania, Rhode Island, South Dakota, Texas, Virginia and Wisconsin named
- Medical device recall Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or… Investigation determined that units supplied were missing the 4x21 degree helix angle. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system Philips had discovered through a field service testing where a device failed to comply with a Federal standard. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Biomedix SELEC-3 I.V Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Class IIFDA’s classOct 15, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNorth Carolina, Ohio and Texas
- Medical device recall Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration… Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN… NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE… NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE… NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE… NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass 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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