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 Recall Communication: Medical Device Model Recall Notification Letter 

 Ron Brown

SLIDE 1

Welcome to CDRH Learn. CDRH Learn is a training program developed by FDA's 

Center for Devices and Radiological Health, and is designed to bring you training 

on a wide range of topics that involve the regulation of and policies related to 

medical devices and radiation products.

I am Ron Brown, the Acting Recall Branch Chief, for the Division of Risk 

Management Operations. Today, I am going to discuss the Medical Device Model 

Recall Notification Letter

SLIDE 2

What are some of the Recall notification requirements for a company?

The recalling company is responsible for Promptly notifying each of its affected 

direct accounts that is, distributors, contractors, and customers, about a recall. 

A recall communication can be in the form of a press release, telephone call, 

telegram, mailgram, or a first class letter. It is highly recommended that the 

recalling firm discuss a recall letter with their FDA district recall coordinator 

before issuing the notification.

The web addresses at the bottom of this slide are references for you to obtain 

further information.

SLIDE 3

What are some of the reasons for a company's notification?

-- To provide details regarding the product recall,

-- To supply information to help users identify the product, and

-- To minimize health consequences by providing instructions on what action or 

actions need to be taken.

SLIDE 4

-- Mark a First Class Letter and envelope, preferably in bold red type, with the 

words -- "URGENT Medical Device Recall."

Mark "Urgent" for all Class I and Class II recalls and, when appropriate, for Class 

III recalls. 

-- Document all communication related to the notification. 
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SLIDE 5

Note that the Notification template is divided into sections. The sections are 

numbered for reference, but the numbers are not part of the notification. 

The letter template, as shown here, has been broken into sections to make it 

easier to quickly get the information needed. 

The section headers should be in bold text to provide an easier visual reference 

and consistency.

SLIDE 6

The Recall notification title must include:

-- the company Name

-- the date the notice is released

-- the words "URGENT Medical Device Recall" typed in capital letters, 

-- and the product name, which must be prominently displayed. 

SLIDE 7

Now let's discuss the Recall Notification Letter.

^

SLIDE 8

Please follow the arrows as we go along. The Greeting to Customers is fairly 

straight forward and contains the basic information about the user. Also included 

in this section are details of who the company is and what device they are 

voluntarily recalling. This section should also include the identification 

information for the product in question, as well as details of any serious adverse 

events associated with the product. This information should be in bold text and 

include the number of injuries that have been reported to date.

The next section, indicated by the arrow, shows the Reason for the Voluntary 

Recall. This should provide as much detail regarding the issue as possible, 

including:

-- frequency of the failure occurrences, 

-- the number of complaints received to date,

-- and any Adverse Events including what types of injuries have been seen as a 

result.

SLIDE 9

The next section references the footnotes located at the bottom of the slide to the 

left.
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SLIDE 10

On this slide we would like to point out that recall notifications are recommended 

for Class I and II recalls. "Urgent" should be noted on both the letter and 

envelope as per 21 CFR 7.49(4)(b). 

Please also note that for radiation emitting devices, the recall action is regulated 

under 21 CFR 1004, which requires manufacturers to bring the affected product to 

conformance at no charge to the user. This varies from the requirements of 21 

CFR 806 for Medical Device recalls.

SLIDE 11

The next section is the Risk to Health and Actions to be taken by the Customer or 

User.

SLIDE 12

Risk to Health. The firm should provide a detailed description of what risk the 

device failure will pose to the user. 

For example, what hazard is the likely outcome of the device failure? Is it an 

injury, a delay in therapy, inappropriate therapy, etc? 

If the failure is detectable, be sure to highlight that in bold text for the user. 

Please provide the information in lay terms. Anything that helps the user 

recognize the failure early is good! 

Our next Section -

"Actions to be taken by the Customer or User" should detail the steps the user or 

customer should take. For example: discontinue use of the product, discard it, or 

correct it. 

At a bare minimum, these instructions should include treatment or actions to 

minimize risks, action to take pending corrective action, list of alternative 

products, instructions for any associated recalls, and the instructions for 

acknowledgement of the recall. 

SLIDE 13

Next we have the Product Distribution and Actions taken by the Company 

section.

SLIDE 14

Our "Product Distribution" section contains the product identification information 

provided by the manufacturer. 

This includes the Product Name, the manufacturer's product number, the lot or 

serial number, the manufactured or distribution dates, the quantity, and 

expiration date, if applicable.
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The "Type of Action by the Company" section provides any actions that the 

manufacturer is taking to correct this issue. This includes actions such as 

providing a system update, market removal, or change in labeling. Also, provide 

details on when these actions will be taken and whether these are long term or 

short term corrections, any findings from the Failure Investigation should be 

provided here.

SLIDE 15

Our next section is reserved for other important information that has not been 

provided.

SLIDE 16

This section should include contact information for the user or customer. It 

should also list details for acknowledging receipt of the recall notification and 

provide information for reporting adverse events to the FDA.

SLIDE 17

Please remember that the format, content, and extent of the notification should 

correspond with the recall hazard and strategy.

SLIDE 18

A Notification letter should include a Return Response form that the customer 

can use to acknowledge receipt of the communication. It's key that customer or 

user have a means of responding and acknowledging that they received the 

notice and have taken appropriate action.

SLIDE 19

This slide provides examples of Inappropriate Information in a Recall Notification, 

such as:

-- Qualification data

-- Promotional materials, or

-- Any other statement that may detract from the message.

SLIDE 20

Notification Follow-up. Whenever necessary, additional communication should be 

sent to customers who fail to acknowledge receiving the initial notice.
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SLIDE 21

This slide shows Consignee and Distributor Responsibilities.

Upon receipt of a recall notification, Consignees and Distributors should follow 

the instructions set forth by the recalling firm, and when necessary, extend the 

recall to its customers in accordance with the instructions provided by the firm.

SLIDE 22

In conclusion, notification letters must provide clear details regarding the issue 

and the health risk to users.

Information identifying affected products must be easy to find.

Actions to be taken by the users should be bulleted or numbered to clearly 

articulate the requirements needed to minimize the risk or impact of the affected 

product. And the notification should be sectioned to allow the user to quickly see 

the information needed.

SLIDE 23

If you have further questions regarding reporting requirements, contact your 

local FDA District Recall Coordinator or refer to the other sources listed on this 

slide.

Thank you. 

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