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 Fabius MRI, anesthesia machine The automatic ventilation may fail if the position detection of the motor is disturbed. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Idaho, Illinois, Kansas, Massachusetts, Michigan, Mississippi, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Fabius GS Premium, anesthesia machine The automatic ventilation may fail if the position detection of the motor is disturbed. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Idaho, Illinois, Kansas, Massachusetts, Michigan, Mississippi, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Fabius Tiro, anesthesia machine The automatic ventilation may fail if the position detection of the motor is disturbed. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Idaho, Illinois, Kansas, Massachusetts, Michigan, Mississippi, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Fabius Tiro M, anesthesia machine The automatic ventilation may fail if the position detection of the motor is disturbed. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Idaho, Illinois, Kansas, Massachusetts, Michigan, Mississippi, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer Product Usage: The… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The AirLife… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, 40” oxygen reservoir tubing 6/cs Product Usage: The AirLife… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter Product Usage: The AirLife… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve Product… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor,… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve Product Usage:… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve Product Usage: The AirLife… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Product Usage: The… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer,… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product… The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Capio SLIM Suture Capturing Device Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Capio SLIM Box 5 Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures. Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Capio Open Access Box 4 (Capio OPC) Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Capio Standard Box 4 (Capio PC) Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist… Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Uphold LITE w/ Capio SLIM Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Posterior LITE w/ Capio SLIM Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall PFR Kit- Pinnacle, Anterior Apical Recalled by FDA on May 16, 2018 Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
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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