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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product Usage: This is sterile,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage:… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD Product Usage:… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD Product Usage:… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage:… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD Product Usage:… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named
- Medical device recall DORO LUCENT Base Unit The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereCalifornia, Georgia, Mississippi, Ohio, Tennessee, Texas and West Virginia
- Medical device recall DORO LUCENT Locking Transitional Member The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereCalifornia, Georgia, Mississippi, Ohio, Tennessee, Texas and West Virginia
- Medical device recall DORO LUCENT Transitional Member The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereCalifornia, Georgia, Mississippi, Ohio, Tennessee, Texas and West Virginia
- Medical device recall AIRO Mobile CT System The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OptiView DAB IHC Detection Kit Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ultraView Universal DAB Detection Kit Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall iView DAB Detection Kit Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ultraView SISH DNP Detection Kit US Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall OptiView Amplification Kit Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall iView DAB Detection Kit w/o Secondary Antibody Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ISH iVIEW Blue Plus Detection Kit Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ANTI-PAN Keratin Primary Antibody, 25 mL Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ultraView Universal Alkaline Phosphatase Red Detection Kit Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ISH Protease 3 Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CONFIRM anti-Progesterone Receptor (PR) Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall VENTANA ISH iView Blue Detection Kit Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall VENTANA Basal Cell Cktl Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall VENTANA anti-Helicobacter Pylori (SP48) PAB 250 Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CINtec Histology Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CINtec p16 Histology Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CINtec p16 Histology Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall INFORM HPV III Fam 16 Probe - US Export Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall NEXES VEN IVIEW DAB DET KT JPN-US EXPORT Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ultraView SISH DNP Detection Kit Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Leica M525 F20 Surgical Microscope System The firm received complaints that the instrument tipped over when the swing arm was fully extended. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Gentle Thread PLGA Round Head Interference Screw, 7x20mm The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereIndiana and Tennessee
- Medical device recall Gentle Thread PLGA Full Thread Interference Screw, 10x30mm The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereIndiana and Tennessee
- Medical device recall Permobil powered wheelchairs This correction decision has been made because of a potential failure of one or both backrest bars providing back support. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 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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