Guide for recalling medical devices (GUI-0054): Recall process

On this page

• Overview of recall stages
• Stage 1: Identify the need to initiate a recall
• Stage 2: Develop recall strategy and scope
• Stage 3: Notify and correct
• Stage 4: Follow up
• Stage 5: Review and close recall
• Charts showing recall stages
• Recall process checklist

Overview of recall stages

Section 58(b) of the Medical Devices Regulations (regulations) states:

The manufacturer, importer and distributor of a medical device shall each establish and implement documented procedures that will enable them to carry out an effective and timely recall of the device.

Also, under section 45(g), a manufacturer, importer or distributor who holds a medical device establishment licence (MDEL) must attest in the application that they have these documented procedures in place.

This guide divides the recall process into 2 main parts:

1. Initiating a recall
2. Conducting a recall

The recalling company initiates a recall and conducts the recall for their consignees. Other companies such as importers and distributors further down the distribution chain also participate in the recall and notify their consignees.

Manufacturers are ultimately responsible for the device's safety and effectiveness and therefore initiate most of the recalls.

However, importers and distributors must be able to initiate recalls if the:

• cause of the defect or problem is related to their activities (for example, storage or handling issues) or
• manufacturer is not willing or able to carry out a recall

The recall process can be further divided into the following 5 stages.

Initiating a recall:

1. Identify the need to initiate a recall
2. Develop recall strategy and scope

Conducting a recall:

3. Notify and correct
4. Follow up
5. Review and close recall

Companies that initiate a recall are involved in all 5 stages. Companies that conduct a recall initiated by another company are involved in stages 3, 4 and 5.

Stage 1: Identify the need to initiate a recall

Manufacturers should initiate a recall action if they become aware the device (including its labelling) is defective or potentially defective and may:

• may present a risk of injury to health
• fail to meet any claim made by the manufacturer or importer about its effectiveness, benefits or safety
• not meet the requirements of the act or regulations

You might become aware of a defect or deficiency with a device through complaint investigations, inspections, or internal quality control testing or audits (for example, for a non-conforming product).

A defect may be related to:

• software errors
• design deficiencies
• labelling problems
• compliance issues
• for example, related to device licensing
• manufacturing problems
• component defects or failures
• improper shipping, installation or servicing

If you manufacture medical devices, you must have a means for determining when to:

• correct a device
• remove a medical device from the market
• notify owners and users that using a device carries risk

Your quality system should include ways to identify defects or deficiencies and determine if a recall is needed. It's your responsibility to determine the:

• level of risk associated with the defects or deficiencies and
• the actions that are required to correct them (such as investigating a complaint or non-conforming product, taking corrective or preventive actions)

Taking action to fix problems with a device that has been distributed is considered a "correction" and in most cases will meet Health Canada's definition of a recall. In addition to a correction, you should likely take preventive action to prevent the problem from happening again.

Submit a 24-hour recall notification to Health Canada

Under section 63.2 of the regulations, the manufacturer or importer must notify Health Canada if the defect or deficiency is likely to cause injury or serious injury to the health of patient, user or other person. Notification must be made within 24 hours after the decision is made to conduct a recall in Canada.

Stage 2: Develop recall strategy and scope

Manufacturers should also have a recall strategy in place that enables you to:

• evaluate the risk in detail
• determine depth of the recall within the distribution chain
• identify customers who may be affected
• develop recall communications
• ensure timeframes
• identify companies that are responsible for notifying clients
  • you may get distribution lists from importers and distributors and conduct the recall notification for end users on their behalf
• indicate how to notify users who are not readily identifiable
• evaluate if any licence amendment(s) including significant change are required to the medical device
• evaluate the effectiveness of the actions taken
• determine initiation date, progress reports to Health Canada and anticipated closure date

In developing the strategy, you should consider the following:

• results of your risk evaluation
• risk type assigned to the recall
• ability to easily identify the recalled device
• degree to which the device's defectiveness is obvious to consumers or users
• degree to which the device remains unused in the marketplace
• availability of comparable products that could be used instead of the affected device

Reporting recalls to Health Canada

Under section 64 of the regulations, both manufacturers and importers must report recalls to Health Canada. This step must be clearly indicated in your recall procedure.

Note: If a recall initiated by a manufacturer involves an importer, both have to report the recall to Health Canada. However, the use of the word "or" in the regulations allows for situations where an importer may initiate a recall (for example, due to a storage or handling issue) and the manufacturer is not involved. In this case, only the importer must report.

Evaluating risk

Recall procedures require companies to evaluate the risk associated with a device when they are developing their recall strategy. The extent and type of the recall action depend on the hazards and harm associated with using the defective device.

When you evaluate risk, consider the following:

• nature and degree of the hazard and harms
• nature of the particular population at risk
• size of the population at risk
• degree of the customer's competence in using the device
• customer awareness of the problem
• any disease, injury or death that has occurred from using the device
• probability that the issue will happen again
• user's ability to detect the problem

Use the results of your risk evaluation to assign a health hazard classification (Type I, II or III) for the recall:

• Type I: A situation in which there is a reasonable probability that the use of (or exposure to) a device being recalled will cause serious adverse health consequences or death.
• Type II: A situation where the use of (or exposure to) a device being recalled may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
• Type III: A situation where the use of (or exposure to) a device being recalled is not likely to cause any adverse health consequences.

Note: Types I and II include situations where a device that does not have recognized or scientifically supported therapeutic value is promoted over the recognized therapy. The consequence is that injury or death could occur.

You must include your completed risk evaluation in your initial recall report. We will assess the information you provide, including the type you assigned to the recall. If we determine the type to be a higher level, we may contact your company to discuss a revised strategy.

Evaluating licence amendment including significant change

Manufacturers are required to evaluate corrective actions that involve Class II, III and IV medical devices to determine whether these actions require a licence amendment, as per section 34 of the MDR. A medical device licence amendment is required for any intended recall action that includes a:

• change that would affect the class of the device
• change in the name of the manufacturer or name of the device
• change in the device identifier
• change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented in the case of a Class II medical device other than a decorative contact lens
• a significant change in the case of a Class III or IV medical device

"Significant change" is a change that could reasonably be expected to affect the safety or effectiveness of a medical device. Section 1 of the regulations defines this as a change to:

• manufacturing processes, facilities or equipment
• manufacturing quality control procedures
  • including methods, tests or procedures used to control the quality, purity and sterility of the device or the materials used in its manufacture
• design of the device, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories and
• intended use of the device, including any new or extended use, such as adding or deleting a contraindication for the device, and any change to the expiry date

Submit this application to Health Canada's Medical Devices Directorate, describe the change and clearly indicate it's related to a recall, when applicable. Obtaining the amended licence before you implement the corrections may mitigate the potential for ineffective corrections in the field. This should not delay notifying customers of the recall and providing temporary measures to mitigate the risk associated with the recall.

The results of your licence amendment review should be included in your final report to us, as stated in section 65.

Learn more about significant change:

• Guidance for the interpretation of significant change of a medical device

Depth of recall within the distribution chain

A recall strategy must define the "depth" of the recall (how far in the distribution chain the recall will extend). Depth should be based on the type of device (including where and how it's used) and the risk the device poses to the public.

A recall may extend to the:

• user level
  • health care facilities, health care providers
• distributor level
  • including to importers
• retail level
• general public
  • consumers, patients

Timeframes

Your recall strategy must define timeframes for key activities.

When initial communication is not the sole recall action, you must have a detailed plan that shows estimated timeframes for accomplishing the remaining actions. The plan should reflect the:

• complexity of corrective actions
• number and geographic location of customers
• risk associated with the affected device
• validation requirements
• continuing availability of essential products

Recall communications

Your recall strategy must outline the method and content for all communications associated with the recall. In general, recall communications include:

• a description of the device, including:
  • model number
  • lot number
  • serial number
  • other information to help identify the device (such as software version)
• the reason for the recall (such as the risks associated with its use)
• when appropriate, that further distribution or use of the remaining product must stop immediately
• when appropriate, instructions to your customers who may have further distributed the device to forward the recall communication to their own customers
• when appropriate, instructions for disposing the product, with specific steps for return, disposal or correction
• request for a prompt response to confirm receipt of the recall communication

To encourage a quick response from customers or other companies, you could consider providing:

• pre-addressed cards
• telephone replies using a toll-free number
• a form to complete and return by fax or email

Clearly mark your written Type I and II recall communications (including notifications, cover sheets and envelopes) by displaying Urgent medical device recall in bold, red font.

The recalling company is responsible for sending out recall communications. When carrying the recall forward, other companies may send out their own communications to their customers as well, along with those of the recalling company.

Notifying users who are not easy to identify

Recall strategies must also consider how to contact medical device users who are not easy to identify. In these cases, you may consider communicating in other ways, such as through a public notification. This is usually reserved for situations where the risk is classified as Type I or Type II.

Public notification may take different forms, depending on the nature of the population at risk. You could make announcements to the public through the media or by posting on websites. You could target specialized media (such as professional or trade presses) or certain segments of the population (such as doctors, hospitals or clinics).

Note: While the recalling company has the main responsibility for notifying the public, in certain cases Health Canada may issue a public notification to inform people in Canada of a serious health risk. This authorization is set out in the Department of Health Act.

Stage 3: Notify and correct

This stage begins when the recalling company notifies affected consignees (anyone who received or bought the affected device) of the recall. It may involve several sub-stages and includes the initial notification. It may also include actions taken to mitigate the risk or resolve the issue (for example, corrections or device replacement).

This stage also applies to consignees such as importers or distributors who have further distributed the product. Their recall procedures must clearly show the steps to follow when their company receives a recall, and name the person or staff position responsible for each step.

Quarantining the affected product

Review current stock to identify and quarantine any affected product still under your control.

Quarantine measures can include physical quarantine as well as electronic quarantine methods to prevent products from being distributed.

Identifying affected clients

Your recall procedures should describe how to generate a distribution list of affected customers. You will also need a method for locating customer contact information. Distribution lists must account for devices distributed by any means, including through:

• sales
• rentals
• loaners
• samples
• demonstration devices

The degree to which you are able to trace distribution records determines how many clients you will need to contact. For example, during a recall for a specific lot or serial number, you would only need to notify the customers who received the affected lots.

Once you have identified affected clients and are ready to begin the notification process, you must submit your initial recall report to Health Canada, as stated in section 64 of the regulations.

Method of notification

Describe in your recall procedures how you will communicate with affected clients. You can identify both primary and secondary methods of communication.

Make every effort to ensure you contact the most appropriate individual. Include contact information in the distribution records. Large health care facilities may keep more than 1 contact (for example, a contact for purchasing and a contact for recalls, such as a risk manager).

You can use several means to contact affected clients, including, for example:

• fax
• email
• personal visits
• telephone calls
• special delivery letters
  • for example, registered mail, courier

Regardless of the method, you must document in writing all forms of contact, especially when using telephone calls or other personal means.

Notification timeframes

Your recall procedures must specify prescribed timeframes to initiate contact with affected clients.

If your company was involved in distributing the affected product, you are responsible for promptly notifying each of your consignees about the recall.

Follow these guidelines for making initial contact after starting a recall:

• For Type I recalls: 1 to 2 business days.
• For Type II recalls: 3 to 5 business days.
• For Type III recalls: 5 to 7 business days.

If you cannot contact consignees in these timeframes, you must provide a rationale in your recall strategy.

Your recall strategy should also indicate a reasonable response time for hearing from consignees.

Tracking responses to recalls

Your recall procedures should require that responses be tracked and describe how you will track them.

Companies involved in a recall are expected to maintain records showing that they made appropriate efforts to contact all consignees. These records could include:

• dates of attempted contact
• name and title of person you contacted
• means of contact
  • for example, telephone, fax, email, mail details
• details of communications once contact is successful
• whether recall instructions were understood and carried out
• response received at each attempt
• copies of completed response forms
• copies of related correspondence

Evidence of contact could include a fax-back form, email response or telephone log. Document details of all contact you make with a client and follow up with anyone who does not respond.

Completing and tracking recall actions

The recalling company must also complete and track other required actions related to the affected product (for example, product removal or correction).

Once you receive confirmation that your initial notification of the recall was received, you should complete other actions related to the recall. Actions could include:

• returning the device to destroy or rework
• having the client destroy the device onsite
• having the client inspect or test the device onsite
• providing parts to the client so they can correct or retrofit the device
• providing new labelling
• patching or upgrading software
• inspecting, testing, correcting or retrofitting the device at a client's location
• returning the device for inspection, testing, correction or retrofitting

Track each action you complete. Because some recalls involve multiple actions, you may want to use spreadsheets or databases to track completed actions.

Collecting the affected product

Your recall procedures must identify how the recalled device should be handled until it is disposed or corrected. Due to potential risks, any returned product must be controlled to prevent it from being further used or distributed.

Stage 4: Follow up

Specify the steps required to follow up on the corrective actions described in your recall procedures. Follow-up could include:

• evaluating the recall's effectiveness
• taking remedial actions
• disposing of the affected product

Evaluating recall effectiveness

When the recall is complete, evaluate its effectiveness by tracking the number of responses you received following your notification process. You could also track how successfully your company completed corrective actions.

Your recall strategy should specify how to evaluate the effectiveness of a recall (for example, responses to the initial notice, corrections or returns). In most cases, you can monitor the effectiveness of the initial notification by the level of customer response (for example, number of fax-back forms received). Responses may involve written acknowledgement that the customer received, read and understood the recall. You may also require customers to provide information about the status of affected devices.

Following up with non-responders

If customers do not respond to the initial notification, you must follow up. "Non-responders" are people from whom you do not receive a return fax, email, courier or phone message.

Your recall procedures should outline how you will follow up with non-responders. Use the following guidelines:

• Type I: No non-responders may remain. Due to the high level of risk, all customers must be aware of the recall as soon as possible. If needed, make a personal visit to inform customers of the recall. You must justify and have records of each follow-up attempt for any non-responders that remain.
• Type II: Follow up with non-responders 2 more times using different contact methods. Keep records of each follow-up attempt.
• Type III: Make 1 more follow-up attempt, preferably using another means of contact.

In addition to monitoring responses, consider information provided by users, especially if it indicates the recall was not effective. For example, there may be cases where the problem affects other products or lots not specified in your original recall notice, or where a correction creates a new problem.

If you cannot easily identify customers who own or have used the affected product, provide a way for them to respond (such as through public notices with toll-free numbers). In this case, you may not be able to follow up with everyone.

Checking completion of recall actions

Review your tracking mechanism for corrective actions to ensure you have dealt with all affected products. You are responsible for ensuring that all recall actions are complete.

Review all information you collect during this evaluation step to determine if you must take additional action to address risk. This may include revising your recall strategy.

Health Canada effectiveness checks

After you complete your communication with consignees and follow up with non-responders, we may review your customer contact records and the effectiveness of your recall strategy.

Product disposition

When a product is returned, you should dispose of it as outlined in your recall strategy. Keep appropriate records to show that this has been done.

Stage 5: Review and close recall

Steps required to review and close completed recalls include:

• doing a final review
• submitting a final recall report to us
• closing the recall
• completing final documentation

Final review

A final review is done to determine if the recall can be closed. You should only close a recall once all notifications, corrections and follow-up actions have been completed and the problem has been addressed.

A qualified person or group must conduct the final review to make sure the recall file contains or references records for all recall actions. The following information, as applicable, must be reviewed:

• number of units recovered
• number of units consignees used
• number of units consignees destroyed (as requested in the recall notice)
• number of units corrected (modified, repaired or retrofitted), either on- or offsite, and returned to consignees
• number of units that could not be located
• method or intended method used to dispose of any recovered units or stock units
  • evidence of disposition should be available to us on request
• final completion date for the recall
• assurance that all consignees received the recall information
  • evidence should be available to us on request
• detailed plan to prevent the problem from happening again and to resolve the problem using measures such as:
  • design change
  • process validation
  • increased quality control
• verification of the device licence amendment review, including an evaluation of significant change for Class III and Class IV medical devices

Reviewing the completed recall can:

• give you valuable information about recall strategies and procedures
• help you refine your approach to prepare for future recalls

Notifying Health Canada that the recall is closed

After the final review is done and it's been determined that a recall can be closed, importers and manufactures must submit a final recall report to Health Canada within 30 calendar days after completing the recall. This is required under section 65 of the regulations.

This step must be clearly indicated in your recall procedure.

Closing the recall

You must document the closure of your recall. The person you choose to close the recall should be familiar with all aspects of the recall process, and must sign and date the documentation.

When we receive your final recall report, we will send you a letter to confirm that the recall is closed.

Completing final documentation

Manufacturers, importers and distributors must keep sufficient documentation to show that the necessary recall actions were completed in a timely and effective manner and complied with the regulations.

Charts showing recall stages

The following charts show the stages of the recall process.

Chart 2 covers all stages of the process and applies to manufacturers or other companies who initiate a recall.

Chart 2: Recall process for company initiating the recall

Long description

This flowchart is divided into 2 sections called "initiating recall" and "conducting recall". These sections are further subdivided into a total of 5 stages.

There are 2 stages in the "initiating recall" section. Stage 1, "determine need for recall", begins with a box that lists the types of corrective and preventive actions that may trigger a recall. Actions include:

• risk controls identified during complaint investigations
• quality deficiencies, such as a non-conforming product
• regulatory compliance following inspections
• sale of unlicensed devices

If a company has taken these or similar actions, they are directed by an arrow in the flowchart to ask 2 questions to help them determine whether a recall is triggered.

First question, "Is action required on product that has been distributed?" If the answer is no, the company is directed to "continue with corrective or preventive actions". No recall is triggered. If the answer is yes, the company is led to the second question, "Does action meet the criteria in definition of recall (decision to recall)?". If the answer is no, the company is directed to continue with corrective or preventive actions. No recall is triggered. If the answer is yes, the company is led to the third question, "Is the recall reportable?" If the answer is no, the company is directed to "not notify Health Canada, however proceed with recall process." If the answer is yes, the company is directed to notify Health Canada within 24 hours after making the decision to recall.

The company continues to stage 2, which is to develop a strategy. Here, the company is directed to define the recall parameters or strategy. The box in the chart lists the following parameters:

• affected products, as identified by their model and lot number
• risk evaluation and risk type
• actions required
• depth
• disposal of the product
• correction logistics

The company is also directed to develop recall communications, which lists the following elements:

• develop communications
• method of communication
• tracking method

This brings the recalling company to the second section, "conducting recall". This section is divided into stages 3, 4 and 5. Stage 3, "notify and correct", directs the recalling company to identify affected parties, which lists:

• review of distribution
• records, including loaners, rentals and demo

One arrow from this box points to a box that indicates to notify customers or consignees. Another arrow points to a box that indicates to submit initial recall report to Health Canada on or before staring the recall. Then, the recalling company is directed to a box that indicates to notify customers and monitor responses, then to:

• collect the product or place in quarantine and
• make field corrections

The recalling company is then directed to submit progress reports to Health Canada. The next stage (stage 4) is to follow up. In this stage, the recalling company is directed to evaluate effectiveness, which involves:

• following up with non-responders and
• ensuring required actions are completed

The recalling company is next directed to either reconcile the affected product or take additional actions if required.

The final stage (stage 5) is to review and close, which involves records and documentation. The recalling company is directed to either:

• correct or dispose of affected product or
• submit final report to Health Canada within 30 days after completing the recall

Chart 3 is for importers and distributors who are conducting a recall initiated by a manufacturer.

Long description

The flowchart is divided into 3 stages: "notify and correct" (stage 3), "follow up" (stage 4) and "review and close" (stage 5).

Stage 3 (notify and correct): The company receives a notification of a recall initiated by another company. Two questions are posed to help the company through next steps. If the answer is no to question 1, "Does the recall apply to establishment's products?", the company responds to the recall initiator. If the answer is yes, the company determines if the products have been distributed. Those that haven't are quarantined. If the products have been distributed, the company is directed to take 1 of the following actions:

• review recall procedure
• review current stock
• determine method of communicating recall information
• prepare additional communication

For each of these actions, the company is directed to quarantine any affected products still in storage and to:

• identify affected parties, such as other distributors and retailers (if applicable) and submit an initial recall report to Health Canada if an importer
• notify customers and monitor and track responses
• perform other corrections specified by the company that initiated the recall, such as inspecting, testing or removing products and reporting these back to the company that initiated the recall

Stage 4 (follow up): This stage involves 2 actions:

• evaluate effectiveness, which involves following up with non-responders, ensuring required actions are completed and taking additional action if required
• collect and reconcile recalled products

Stage 5 (review and close): This is the final stage. Companies are directed to dispose of affected products and maintain records and documentation. Then they are to:

• respond to the company that initiated the recall
• submit a final report to Health Canada within 30 days after completing the recall (importers only)

Recall process checklist

The following checklist is a valuable tool you can use to evaluate the adequacy of your company's recall procedure and understand the specific steps to follow during a recall process. It is not intended to provide an exhaustive description of the recall process.

Our company's recall procedures include:

• definitions of key terms, including "recall"
• the person(s) responsible for managing recalls

Part 1: Initiating a recall

If they wish to designate the importer to submit recall reports on their behalf, manufacturers must submit a written notification to Health Canada confirming that the importer accepts the recall report designation.

Email: meddev-matmed@hc-sc.gc.ca

Stage 1: Determine the need for a recall

• Our company's procedures address recalls that we initiate within our company versus recalls that are received from a supplier or manufacturer.
• We have linked any procedures that may be sources of recalls (for example, complaint handling, corrective and preventive actions or handling non-conforming products) to our recall procedures.
• Our procedures state the need to submit a 24 hour recall notification to Health Canada once a decision has been made to recall medical devices in Canada (also applies to importers if they initiate recalls).

Stage 2: Develop a strategy

• Our procedures describe the steps for developing a recall strategy, including factors to consider when researching and writing the strategy.

Part 2: Conducting a recall

Stage 3: Notify and correct

• Our procedures describe the recall notification process.
• Our procedures have set timeframes to ensure that recalls are initiated in a timely fashion, according to the level of risk.
• Our procedures require importers and manufacturers of the medical device to provide Health Canada with an initial recall report.
• Our procedures outline how we will communicate a recall to affected clients (for example, by fax, email or phone). They include any requirements for affected clients to provide an acknowledgement or response when we issue a recall notification.
• Our procedures specify how we will track acknowledgements and responses from affected customers.
• Our procedures specify how a returned product is to be quarantined until it can be corrected or disposed of.

Stage 4: Follow up

• To allow us to evaluate the effectiveness of a recall, our procedures describe how we will track responses from notified customers as well as the completion of our recall actions.

Stage 5: Review and close recall

• Our procedures specify criteria for closing a recall.
• Our procedures require that senior management reviews and signs off on a recall closure.
• Our procedures specify how we will create records showing that each step of the recall was completed. They also specify where, how and how long this documentation will be stored.
• Our procedures require importers and manufacturers to provide final recall reports to Health Canada within 30 calendar days after completing the recall.