Recalls, Corrections and Removals (Devices)

Overview

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. 21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.

Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority. 21 CFR 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act (Act).

Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.

Definitions

Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.

Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

Recall means a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

Recall strategy means a planned course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.

Recalling firm means the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled.

Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

Risk to health means (1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or (2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.

Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.

Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use.

Voluntary Recalls - 21 CFR 7

A recall is an alternative to an FDA-initiated court action for removing or correcting violative products that have been distributed. 21 CFR 7 sets forth specific recall procedures for FDA to monitor recalls and assess the adequacy of a firm's efforts in recall. Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the FDA. A request by the FDA that a firm recall a product is reserved for urgent situations and is directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled.

Recall does not include market withdrawal or a stock recovery. A market withdrawal is a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. Almost all recalls are conducted on a voluntary basis by the manufacturer.

Please note an electronic product that emits radiation and is subject to 21 CFR 1003 and 1004 is not subject to the requirements under 21 CFR 7.

Health Hazard Evaluation

An evaluation of the health hazard presented by a product being recalled or considered for recall is conducted by FDA and takes into account, but need not be limited to, the following factors:

Whether any disease or injuries have already occurred from the use of the product.
Whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard. Any conclusion shall be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion of the individual(s) making the health hazard determination.
Assessment of hazard to various segments of the population, e.g., children, surgical patients, pets, livestock, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be at greatest risk.
Assessment of the degree of seriousness of the health hazard to which the populations at risk would be exposed.
Assessment of the likelihood of occurrence of the hazard.
Assessment of the consequences (immediate or long-range) of occurrence of the hazard.

On the basis of this determination, the FDA will assign the recall a classification, i.e., Class I, Class II, or Class III, to indicate the relative degree of health hazard of the product being recalled or considered for recall.

Classification

Recalls are classified into a numerical designation (I, II, or III) by the FDA to indicate the relative degree of health hazard presented by the product being recalled.

Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Recall Strategy

The recalling firm should develop a recall strategy that takes into account the following factors as they apply to the individual circumstances of the particular recall:

Results of health hazard evaluation.
Ease in identifying the product.
Degree to which the product's deficiency is obvious to the consumer or user.
Degree to which the product remains unused in the market-place.
Continued availability of essential products.

The FDA will review the adequacy of a proposed recall strategy and recommend changes as appropriate. A recalling firm should conduct the recall in accordance with an approved recall strategy but need not delay initiation of a recall pending review of its recall strategy.

A recall strategy will address the following elements regarding the conduct of the recall:

Depth of recall. Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, as follows:
- Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or
- Retail level, including any intermediate wholesale level; or
- Wholesale level.
Public warning. The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health. This is reserved for urgent situations where other means for preventing use of the recalled product appear inadequate. The FDA in consultation with the recalling firm will ordinarily issue such publicity. When the recalling firm decides to issue its own public warning, it is requested to submit to FDA its proposed public warning and plan for distribution of the warning for review and comment. The recall strategy will specify whether a public warning is needed and whether it will issue as:
- General public warning through the general news media, either national or local as appropriate, or
- Public warning through specialized news media, e.g., professional or trade press, or to specific segments of the population such as physicians, hospitals, etc.
Effectiveness checks. The purpose of effectiveness checks is to verify that all consignees (at the recall depth specified by the strategy) have received notification about the recall and have taken appropriate action. Consignees may be contacted by personal visits, telephone calls, letters, or a combination thereof. A guide entitled "Methods for Conducting Recall Effectiveness Checks'' that describes the use of these different methods is available from FDA. The recalling firm will ordinarily be responsible for conducting effectiveness checks, but FDA will assist in this task where necessary and appropriate. The recall strategy will specify the method(s) to be used for and the level of effectiveness checks that will be conducted, as follows:
- Level A--100 percent of the total number of consignees to be contacted;
- Level B--Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater than 10 percent and less than 100 percent of the total number of consignees;
- Level C--10 percent of the total number of consignees to be contacted;
- Level D--2 percent of the total number of consignees to be contacted; or
- Level E--No effectiveness checks.

Firm-initiated recall

A firm may choose to remove or correct a distributed product for any reason and under any circumstance. If a firm does this because it believes its product is violative, it is required to immediately notify the FDA. You must contact your FDA’s Office of Regulatory Affairs (ORA) Division Recall Coordinator (DRC) listed here by state or region (look for Product Type “Medical Device”). Foreign manufacturers and importers must contact the DRC where their US agent is located.

Such removal or correction will be considered a recall only if the FDA determines the product is violative. In such cases, the FDA will ask the firm to provide this information:

Identity of the product involved.
Reason for the removal or correction and the date and circumstances under which the product deficiency or possible deficiency was discovered.
Evaluation of the risk associated with the deficiency or possible deficiency.
Total amount of such products produced and/or the time span of the production.
Total amount of such products estimated to be in distribution channels.
Distribution information, including the number of direct accounts and, where necessary, the identity of the direct accounts.
A copy of the firm's recall communication if any has issued, or a proposed communication if none has issued.
Proposed strategy for conducting the recall.
Name and telephone number of the firm official who should be contacted concerning the recall.

The FDA will review the information submitted, advise the firm of the assigned recall classification, recommend any appropriate changes in the firm's strategy for the recall, and advise the firm that its recall will be placed in the weekly FDA Enforcement Report. Pending this review, the firm need not delay initiation of its product removal or correction.

A firm may decide to recall a product when informed by the FDA that the agency has determined that the product in question violates the law, but the agency has not specifically requested a recall. A firm that initiates a removal or correction of its product which the firm believes is a market withdrawal should consult with its DRC if the reason for the removal or correction is not obvious or clearly understood but where it is apparent, e.g., because of complaints or adverse reactions regarding the product, that the product is deficient in some respect. In such cases, the FDA will assist the firm in determining the exact nature of the problem.

Recall Letter

A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In general terms, the purpose of a recall communication is to convey:

That the product in question is subject to a recall.
That further distribution or use of any remaining product should cease immediately.
Where appropriate, that the direct account should in turn notify its customers who received the product about the recall.
Instructions regarding what to do with the product.

A recall communication can be accomplished by telegrams, mailgrams, or first class letters conspicuously marked, preferably in bold red type, on the letter and the envelope: "medical device recall [or correction]". The letter and the envelope should be also marked: "urgent" for Class I and Class II recalls and, when appropriate, for Class III recalls. Telephone calls or other personal contacts should ordinarily be confirmed by one of the above methods and/or documented in an appropriate manner.

A recall communication should be written in accordance with the following guidelines:

Be brief and to the point;
Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product;
Explain concisely the reason for the recall and the hazard involved, if any;
Provide specific instructions on what should be done with respect to the recalled products; and
Provide a ready means for the recipient to report to the recalling firm whether it has any of the product, e.g., by sending a postage-paid, self-addressed postcard or by allowing the recipient to place a collect call to the recalling firm.

The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, follow-up communications should be sent to those who fail to respond to the initial recall communication. A recalling firm is encouraged to discuss the recall letter with its DRC prior to issuing the notification.

Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees in accordance with the instructions described above.

Recall status reports

The recalling firm is requested to submit periodic recall status reports to the its DRC so that the agency may assess the progress of the recall. The frequency of such reports will be determined by the relative urgency of the recall and will be specified by the FDA in each recall case; generally the reporting interval will be between 2 and 4 weeks. Unless otherwise specified or inappropriate in a given recall case, the recall status report should contain the following information:

Number of consignees notified of the recall, and date and method of notification.
Number of consignees responding to the recall communication and quantity of products on hand at the time it was received.
Number of consignees that did not respond (if needed, the identity of nonresponding consignees may be requested by the Food and Drug Administration).
Number of products returned or corrected by each consignee contacted and the quantity of products accounted for.
Number and results of effectiveness checks that were made.
Estimated time frames for completion of the recall.

Recall status reports are to be discontinued when the recall is terminated by FDA.

Termination of a recall

A recall will be terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product. Written notification that a recall is terminated will be issued by its DRC to the recalling firm. A recalling firm may request termination of its recall by submitting a written request to its DRC stating that the recall is effective in accordance with the criteria set forth, and by accompanying the request with the most current recall status report and a description of the disposition of the recalled product.

Public notification of recall

FDA publishes a weekly FDA Enforcement Report that contains all enforcement actions including recalls, field corrections, seizures, and injunctions.

Additional Guidance on Recalls

A recall can be disruptive of a firm's operation and business, but there are several steps a firm can take in advance to minimize this disruptive effect. Notwithstanding similar requirements under the Quality System regulation (21 CFR 820), the firm should take into consideration:

Prepare and maintain a current written contingency plan for use in initiating and effecting a recall in accordance with 21 CFR 7.
Use sufficient coding of regulated products to make possible positive lot identification and to facilitate effective recall of all violative lots.
Maintain such product distribution records as necessary to facilitate location of products that are being recalled. Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention.

Having these procedures in place prior to the initiation of any recall will allow the recall process to proceed in an efficient manner.

Additional information documents on recalls are available:

Regulatory Procedures Manual, Chapter 7 Recall Procedures

Medical Device Class I Recalls

Device Recalls: A Study of Quality Problems , document #273, contact dice@cdrh.fda.gov

"Evaluation of Software Related Recalls for Fiscal Years 1983-91," May 1992, contact dice@cdrh.fda.gov

Mandatory Device Recalls - 21 CFR 810

If, after providing the appropriate person with an opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the FDA may issue a cease distribution and notification order requiring the person named in the order to immediately:

cease distribution of the device;
notify health professionals and device user facilities of the order; and
instruct these professionals and device user facilities to cease use of the device.

The person named in the order will have an opportunity for a regulatory hearing or to provide a written request to FDA asking that the order be modified, vacated, or amended. FDA may later amend the order to require a recall of the device.

Corrections and Removals - 21 CFR 806

Under 21 CFR 806, Medical Devices; Reports of Corrections and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health. A report must be made even if the event was caused by use error. A report is not required if the information has already been provided to FDA under Medical Device Reporting (21 CFR 803) or Repurchase, Repairs or Replacement of Electronic Products (21 CFR 1004) or if the corrective or removal action was initiated by an FDA order under Medical Device Recall Authority (21 CFR 810).

Manufacturers and importers must keep records of those corrections and removals that are not required to be reported to FDA. However, if a report is not required under 21 CFR 806, the firm may voluntarily report under 21 CFR 7.

The definition of "risk to health"' under 21 CFR 806 tracks the definitions of Class I and Class II recalls in 21 CFR 7.3(m). Therefore, reports of corrections and removals are required for Class I and Class II recalls. Under 21 CFR 806, manufacturers and importers need not report events categorized as Class III recalls under 21 CFR §7; only record keeping requirements would apply.

The following actions are exempt from the reporting requirements:

Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device,

Market withdrawals,
Routine servicing, and
Stock recoveries.

Who must report

Manufacturers and importers are required to report a correction or removal of a product if it involves a risk to health. Only the person that initiates the correction or removal is required to report.

When to report

The report must be submitted to FDA within 10 working days from the time the firm initiates the correction or removal . If there is not a "risk to health" involved, a report to FDA is not required, but the manufacturer or importer must keep a record of the correction or removal.

What to Report - §806.10(c)

Registration number, date the report is made, sequence number (001, 002, etc.), "C" for Correction or "R" for Removal.
Name, address, phone number, and contact person of the firm responsible for conducting the correction or removal.
Brand name and common name of the device and intended use.
FDA marketing status, i.e., 510(k), PMA, preamendment status and device listing number.
Model/catalog number, lot/serial number
Manufacturer’s contact information (name, address, phone number, contact person) if different from item #2 above.
Description of event(s) and the corrective and removal actions that have been, and are expected to be taken.
Any illness or injuries that have occurred with the use of the device. If applicable, include any Medical Device Report (MDR) numbers submitted under 21 CFR 803.
The number of devices subject to the Correction or Removal.
Date of manufacture or distribution; expiration date or expected life.
Name, address, and telephone number of all consignees (domestic and foreign) and the dates and number of devices distributed to each consignee.
A copy of all communications regarding the correction or removal.
A statement as to why any required information is not available and a date when it will be submitted.

Where to report

You have two ways to report corrections and removals: FDA Electronic Submission Software (eSubmitter) or e-mail.

1. eSubmitter

We encourage you to submit your report via eSubmitter. Once created, the report is sent to CDRH through the FDA Electronic Submission Gateway (ESG). Instructions on how to use the eSubmitter tool to electronically report corrections and removals may be found using this link: Electronic Submission of 806 Reports of Corrections and Removals

2. E-mail

If you choose to not submit your report via eSubmitter, you must e-mail it to your FDA's Office of Regulatory Affairs (ORA) Division Recall Coordinator (DRC) listed here by state or region (look for Product Type "Medical Device"). Foreign manufacturers and importers must e-mail the report to the DRC where their US agent is located.

Amendments

If, after submitting a report, a manufacturer or importer determines that the same correction or removal should be extended to additional lots or batches of the same device, the manufacturer or importer must amend the original report by submitting an amendment within 10-working days of initiating the extension of the correction or removal [21 CFR 806.10(d)]. The amendment should cite the original report number assigned, all of the information required by 21 CFR 806.10(c)(2), and any information required by 21 CFR 806.10(c)(3) through (c)(12) that is different from the information submitted in the original report. The manufacturer or importer must also state what required information is not readily available and a date for when it will be submitted.

Recordkeeping Requirements

The device manufacturer or importer who initiates a correction or removal of a device that is not required to be reported to FDA must maintain records of the correction or removal. Records must contain the following information:

The brand name, common or usual name, classification, name and product code, if known, and the intended use of the device.
The model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number.
A description of the event(s) giving rise to the information reported and the corrective or removal action that has been, and is expected to be taken.
Justification for not reporting the correction or removal action to FDA, which shall contain conclusions and any follow-ups, and be reviewed and evaluated by a designated person.
A copy of all communications regarding the correction or removal.

The manufacturer or importer must retain all records for a period of two years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained must be transferred to the new manufacturer or importer of the device and maintained for the required period of time.

Regulations

21 CFR 7 – Enforcement Policy
21 CFR 810 – Medical Device Recall Authority
21 CFR 806 – Medical Device Correction and Removals

Federal Register Notices

Note: The Federal Register (FR) is the official daily publication for rules, proposed rules, and notices of federal agencies and organizations, as well as executive orders and other presidential documents. In order to create or revise an existing regulation, FDA will publish a proposed rule in the FR and request comments. FDA will then evaluate all comments received and publish a final rule. Once a proposed rule is finalized, it is published in the Code of Federal Regulations (CFR).

21 CFR 7

Enforcement Policy: Recalls (Including Product Corrections) - Guidelines on Policy, Procedures, and Industry Responsibilities, June 16, 1978. Revised March 22, 1977, June 16, 1978, March 6, 1979, January 27, 1981, March 28, 1994, and September, 19, 2000

21 CFR 806

Medical Devices; Reports of Corrections and Removals, Proposed Rule, March 23, 1994
Medical Devices; Reports of Corrections and Removals; Final Rule; May 19, 1997
Medical Devices; Reports of Corrections and Removals; Direct to Final Rule; August 7, 1998
Medical Devices; Reports of Corrections and Removals; Companion to Direct Final Rule; August 7, 1998
Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment, Final Rule March 10, 2004
806.10(f) No report of correction or removal is required under this part, if a report of the correction or removal is required and has been submitted under 21 CFR 803 MEDICAL DEVICE REPORTING or 21 CFR 1004 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS

21 CFR 810

Medical Device Recall Authority; Final Rule, November 20, 1996
Medical Device Recall Authority; Proposed Rule, June 14, 1994

U.S. Food and Drug Administration

Recalls, Corrections and Removals (Devices)

On this page:

Overview

Definitions

Voluntary Recalls - 21 CFR 7

Health Hazard Evaluation

Classification

Recall Strategy

Firm-initiated recall

Recall Letter

Recall status reports

Termination of a recall

Public notification of recall

Additional Guidance on Recalls

Mandatory Device Recalls - 21 CFR 810

Corrections and Removals - 21 CFR 806

Who must report

When to report

What to Report - §806.10(c)

Where to report

Amendments

Recordkeeping Requirements

Regulations

Federal Register Notices

21 CFR 7

21 CFR 806

21 CFR 810