Product Recall Processes for Medical Devices

FDA recall guidance

September 22, 2014

Product Recall Processes for Medical Devices

The Food and Drug Administration (FDA) provides guidance to regulated industries when it comes to product recalls. These regulated industries include medical and radiological devices. According to regulation, the FDA has the right to recall products. The FDA follows the Code of Federal Regulations (CFR) and specifically 21 CFR 10.115 when it comes to recalls of this type.

If the FDA decides to recall a product

When the FDA makes the decision to recall a product from a firm, a representative from the firm should notify a local FDA District Recall Coordinator before issuing a press release or notifying customers. Firms should find the name of this coordinator from the site.

After the FDA makes a decision to recall a product and someone from the recalling firm notifies an FDA coordinator, the firm should submit as much information as possible to the FDA so that the FDA can review the information and offer assistance in resolving issues.
The FDA provides guidelines concerning this recall submission provided by a firm.
The site that provides the guidelines from the FDA to the firm is

FDA Recall Notice

The site indicates that when providing this recall submission to the FDA, the firm providing the submission should provide the information about the product to include:

  • product name and model
  • product description
  • directions for use
  • serial numbers
  • firm name
  • name of contact
  • name of the manufacturer

A description of the reason for the recall should be part of the submission. The description should explain the product defect and how the defect relates to product performance and safety.  The submission should also include information about:

  • how and when the problem was discovered
  • description of complaints associated with the product

Health hazard assessments

A health hazard assessment should also be included in the submission to the FDA as should information about the volume of the recalled product. Concerning the recall strategy, the firm should indicate:

  • how the firm will provide notification of the recall
    (for example, mail, phone, or email)
  • how letters about the recall will be sent to customers (for example, first class mail)
  • what is the phone script if initial notification will be by phone
  • what are the instructions on what customers are to do with recalled products
  • what is the strategy for non-responders

The FDA also provides guidelines on how to notify the public about product recalls, press releases, product recall notification letters, and instructions to customers.

Recalls and safety alerts

The FDA produces a list of recalls with notices and press releases about the products regulated by the FDA. The public has access to this list at the site.
Here is a sample of what is included in the list.
safety alert

As an example, for the brand name Hospira a recall exists for a problem due to the presence of particulate matter. The product description is Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9 percent Sodium Chloride Injection, 500 mL. The FDA web site provides more detailed information including the press release and other information provided by the manufacturer.

Medical device recalls

For a list of recent medical device recalls, the FDA maintains the site.
Here is an example of what the list is like:


As an example for the Ventlab Manual Resuscitator recalled on May 16, 2014, the problem is that the duckbill valve may stick and prevent air from getting to the patient. The recalled devices were manufactured from January 10, 2013 through July 1, 2013.

The press release that comes from the manufacturer states that this “disposable device is used to provide temporary support to patients who cannot breathe on their own… The duckbill valve inside the resuscitator may stick and prevent air from getting through the valve and to the patient. If a patient does not receive oxygen or treatment is delayed, life-threatening health consequences including inadequate oxygen supply to the tissues (hypoxia) and too shallow or too slow breathing as well as death may occur. The firm received one report of injury requiring medical intervention due to lack of a functioning resuscitation bag.”
This is a Class I recall. According to the FDA site this is the “most serious type of recall in which there is a reasonable probability that use of these products will cause serious adverse health consequence or death.”

Getting updates on medical device problems

If someone would like updates on problems with medical devices, the FDA can provide via their web site a way to sign up for email updates. Additional information about safety communication from the FDA is available by calling 1-800-638-2041 or emailing


Radiation emitting products

The FDA provides at information covering radiation emitting products including information on topics such as:

  • getting a radiation-emitting product to market
  • search for a certified mammography facility
  • internet sales of laser products
  • pediatric x-ray imaging
  • cell phones

Concerning safety related information for radiation-emitting products, the FDA site provides information about:

  • radiation dose reduction
  • nationwide evaluation of x-ray trends (NEXT)
  • electromagnetic compatibility (EMC)
  • mammography quality standards (regulation, guidance, facility certification and inspection)

On the site is additional information about recalls and alerts. A sample of this type of information includes:

  • FDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery
  • list of device recalls
  • report a problem
  • alerts and notices

Reporting a problem with a radiation-emitting product

Here is the page the FDA maintains to report a problem. As stated on the page, manufacturers must report to the FDA all accidental radiation events. Manufacturers should also follow FDA guidelines on recordkeeping and recording regarding radiation emitting products.
Anyone, not just a manufacturer, can use the FDA form available from the following site to report a radiation incident or event that could be hazardous. In addition consumers or health professionals can find a form on this site to report problems with medical products including:

  • serious reactions
  • product quality problems
  • product use errors


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