Recall of Device Recall Covidien

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

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
    Catheter, retention type, balloon - Product Code EZL
  • Reason
    Aplicare castile soap towelettes included in the foley trays and mid stream specimen kits are contaminated with bacteria.
  • Action
    Medtronic/Covidien notfiied customersl via Federal Express on January 22, 2016,, The letter instructs customers to not use the Castile Soap Towelettes contained in the product kits listed on Attachment 1 and discard the affected towelettes. The Castile Soap packet included in these kits does not impact the integrity of the remaining products in the kit. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878. For questions regarding this recall call 203-492-5000.


  • Model / Serial
    Lot Codes: 511059464X 511851964X 513256664X 514650264X 515358464X 516050764X 516858564X 517457464X 520151064X 521058864X 522551264X 522958464X 523657064X 524357064X 525755764X 525755864X
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover PRECSION PRM 16FR SIL FLY || Item Code: PP16SD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer


  • Manufacturer Address
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source