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Medical Device Recalls Rise

Carol Baldwin

Last updated: October 26, 2016 5:06 pm

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Our news media has been saturated with “recall” notices.  Seldom does a week go by without a manufacturer issuing an “official order” for the return of one of its products.  In fact, for the fourth quarter of 2014, medical device recalls increased by a whopping 27 percent. 1

There is no question about the need for safety when it comes to medical devices.  But what if a recalled medical device happens to be implanted in you?

When medical devices, especially medical implants, are malfunctioning or causing problems in patients, medical device manufacturers may consider taking action, sometimes by recalling their product.

Medical Device Oversight

Medical device oversight is the responsibility of the manufacturer and the U.S. Food and Drug Administration (FDA). 2 According to FDA, medical device recalls occur for many different reasons, and the FDA classifies them according to the extent of the problems involved, such as a defect, malfunction or health risk associated with a product.

When a company learns that one of its products or product lines violates FDA law, is defective, could be a risk to health, or both, they must issue a recall and notify the FDA. 3

While FDA has the authority to issue recalls, medical device manufacturers often voluntarily do so, with the FDA involved in the entire process so that the recall is handled in a way that meets FDA laws, regulations and guidelines in order to protect public health. 4

Types of Recall Actions 

A medical device recall doesn’t always mean that the device must be removed from your body or that you must stop using the device completely. 5  A number of types of recall actions may be taken:

  • Notification
  • Re-labeling
  • Inspection and repair
  • Adjustment
  • Monitoring patients
  • Removal and/or replacement
  • Destruction of device 6

FDA Recall Classification System

The manufacturer is responsible for carrying out an adequate recall process.  FDA will check and audit the medical device manufacturer’s process.

The classification of the recall depends upon the potential public health risk posed by the product in question and includes an assessment of FDA’s required involvement in the manufacturer’s recall process. 7

The FDA recall classification system includes three classes:

  • Class I: reasonable chance for serious harm or death
  • Class II: possibility of temporary or reversible health problems
  • Class III: small chance that use or exposure will cause health problems 8

Medical Device Regulations

The safety and effectiveness of medical devices are regulated and controlled by the FDA through basic provisions (authorities) of the May 28, 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act. 9 Provisions relate to the following areas:

  • Adulteration
  • Misbranding
  • Device registration and listing
  • Premarket notification
  • Banned devices
  • Notifications including: repair, replacement or refund; records and reports; restricted devices; and good manufacturing practices 10

FDA controls (laws, regulations, and guidelines) are applicable to all devices regardless of their classification status. 11 The FDA has enforcement powers as well as the responsibility for establishment of guidelines and practices that protect public health.

What to Do if You Have a Medical Device

If you have a medical device implant and are suffering from pain or having other medical issues, and your device was recalled, you should contact your doctors to discuss options.

It is vital that you stay informed about any devices that have been implanted in your body and any tools that might have been used during your surgeries.

For more information about or help with device recalls visit Recall Center.

  1. GQM Weekly Bulletin. Medical Device Recalls Rise 27 Percent in Fourth Quarter (2015).
    http://www.magnetmail.net/actions/email_web_version.cfm?reciptient_id=751650424&message_id=9887198&user_id=FDANews_Ma&group_id=212825&jobid=27206512#story1 Accessed June 17, 2015. 

  2. Food and Drug Administration. CFR-Code of Federal Regulations Title 21. (Sept. 2014). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803&showFR=1&subpartNode=21:8.0.1.1.3.1. Accessed June 17, 2015. 

  3. Food and Drug Administration. Medical Device Safety: What is a Medical Device Recall? (June 2014). http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm. Accessed June 17, 2015. 

  4. Food and Drug Administration. Medical Device Safety: What is a Medical Device Recall? (June 2014). http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm. Accessed June 17, 2015; Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations: 7-6-4 Recall Strategy. (Oct. 2013). 

  5. http://www.fda.gov/iceci/compliancemanuals/regulatoryproceduresmanual/ucm177311.htm#SUB7-6-4. Accessed June 17, 2015. 

  6. Food and Drug Administration. Medical Device Safety: What is a Medical Device Recall? (June 2014). http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm. Accessed June 17, 2015. 

  7. Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations: 7-6-2 Classification Process. (Oct. 2013). http://www.fda.gov/iceci/compliancemanuals/regulatoryproceduresmanual/ucm177311.htm#SUB7-6-2. Accessed June 17, 2015. 

  8. Food and Drug Administration. Recalls, Corrections and Removals (Devices). (October 2014). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/. Accessed June 17, 2015. 

  9. Food and Drug Administration. Regulatory Controls (Medical Devices): General Controls of Medical Devices. (June 2014). http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/generalandspecialcontrols/ucm055910.htm#introduction. Accessed June 17, 2015. 

  10. (Food and Drug Administration. Regulatory Controls (Medical Devices): General Controls of Medical Devices. (June 2014). http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/generalandspecialcontrols/ucm055910.htm#introduction. Accessed June 17, 2015. 

  11. Food and Drug Administration. Regulatory Controls (Medical Devices): General Controls of Medical Devices. (June 2014). http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/generalandspecialcontrols/ucm055910.htm#introduction. Accessed June 17, 2015