Recall Procedure (SYS-020) and webinar bundle

This webinar bundle includes our recall procedure for compliance with ISO 13485:2016, Clause 8.3.3, US FDA, Health Canada, and EU MDR / IVDR.

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The recall procedure is now in its fifth draft of the procedure. The recall procedure meets the requirements for clause 8.3.3 of ISO 13485:2016 and 21 CFR 806 for conducting corrections and removals of products. This updated procedure also meets the requirements for an advisory notices procedure. Matthew Walker updated the procedure to include references to the applicable ISO 13485:2016 clauses, and he added color-coding with symbols to auditors identifying where the requirements for each ISO 13485 requirement are found. The procedure also explains where the requirements for monitoring and measurement of processes can be found for each process.

Which device markets does this recall procedure address?

  1. USA
    • 21 CFR 7 – FDA Enforcement Policy
    • 21 CFR 806 – FDA Corrections and Removals
  2. Canada
    • SOR 98/282, Sections 63-65 – Recalls
    • Health Canada Guidance to Recall of Medical Devices (GUI-0054)
  3. Europe
    • MEDDEV 2.12/1 – Guidelines on Medical Devices Vigilance System
      • Field Safety Corrective Action (FSCA)
      • Field Safety Notice (FSN) Template
    • Regulation (EU) 2017/745 (MDR)
    • Regulation (EU) 2017/746 (IVDR)

There is a separate section specific to each medical device market. As with all of our procedures, you will receive access to free updates of the procedure with your original purchase. The procedure now includes the following content:

Recall Procedure Dropbox folder contents 1024x389 Recall Procedure (SYS 020) and webinar bundle

The two most common causes of recalls are mix-ups in labeling and failure to properly validate software updates. If you are interested in learning more about recalls and labeling, please see our webinar on recalls, labeling, and 21 CFR 820.120. If you would like to learn more about software validation, please consider purchasing our software validation procedure (SYS-044).

Recalls Advisory Notices Procedure Recall Procedure (SYS 020) and webinar bundle
SYS-020 Recalls & Advisory Notices Procedure
Recalls and advisory notices procedure and webinar bundle. The webinar, procedure, and associated forms are available on-demand for download.
Price: $299.00

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. 

When will the webinar be hosted?

The webinar was hosted on July 17, 2024, and the video is available on-demand for downloading anytime.

Recalls Advisory Notices Procedure Recall Procedure (SYS 020) and webinar bundleTo view all available procedures click here

To review a sample Medical Device Academy procedure click below:

managment review sample SOP Recall Procedure (SYS 020) and webinar bundle

2 thoughts on “Recall Procedure (SYS-020) and webinar bundle”

  1. Jeff Pielemeier

    Hello, I assume the SYS-020 Recall procedure is geared toward manufacturers. Do you have one geared toward importers?

    1. Robert Packard

      Hi Jeff,

      Sorry, but we do not have one for importers. In fact, you should not be reporting recalls to the FDA. That is the responsibility of the manufacturer. The importer is responsible for keeping distribution records and assisting the manufacturer with execution of a recall. The manufacturer might even conduct a “mock recall” to verify that the importer has the ability to quickly identify who will need recall notification and what addresses the notifications must be sent to. The ability to generate a list of names and addresses that is in a format that can be used for mail merge is essential. However, there is no requirement for importers to have a recall procedure.


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