Recall of Device Recall Stryker Infravision Esophageal Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bougie, esophageal, and gastrointestinal, gastro-urology - Product Code FAT
  • Reason
    The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.
  • Action
    Stryker issued Urgent Product Recall letters dated August 20, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the affected product to Styrker.


  • Model / Serial
    5687,5766,5815,5822,5833,5872, 5924,60973888,60987814, 61004943, STROll409-l, STROl1409-2, STRO 11609-1, STROl1609-2, STR02l009-1, STR02l009-8, STR022709-l, STR022709-2, STR03ll09-1, STR03ll09-3, STR040l09-l, STR041709-2, STR041709-4, STR0430009-2, STRlO0208-l, STR102208-1, STR102408-l, STRI02708-7, STR103l08-1, STRlll308-l, STR12l808-l, STR12l808-2, STROl1209-l
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution: USA in the states of: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and the countries/region of Australia, Canada, Scandinavia, Italy, and Switzerland.
  • Product Description
    Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.
  • Manufacturer


  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
  • Source