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Medical Device Recalls and Reports of Corrections and Removals, Part 

7, Part 806: Frequently Asked Questions

Introduction

General information regarding recalls, including removals and corrections, is available on the 

Industry Guidance for Recalls webpage: https://www.fda.gov/safety/recalls-market-withdrawalssafety-alerts/industry-guidance-recalls. This resource links to guidances for Industry and Staff 

about the recall process, a listing of Office of Medical Device and Radiological Health and 

Office of Biological Products Operations recall coordinators, the geographic boundaries for each 

recall division, model letters, response forms, and training modules. 

FAQs: Questions and Answers

This section is intended to answer common questions about medical device recalls and reports of 

medical device corrections and removals. This FAQ does not address reports submitted as a 

requirement of the Electronic Product Radiation Control Program (EPRC). 

Q: In what format should we submit our lists of consignee information? 

A: Manufacturers or importers are required to include in their reports of corrections and 

removals the names, addresses, and telephone numbers of all domestic and foreign 

consignees of the device and the dates and number of devices distributed to each such 

consignee. 21 CFR 806.10(c)(11). It is recommended that you submit this information in 

a sortable electronic format, such as a spreadsheet with the names, addresses and 

telephone numbers for the consignees. When feasible, you should include other relevant 

fields in the spreadsheet that might help facilitate follow-up by FDA (e.g., lot numbers, 

shipment dates).1

 

Q: How do I submit the Unique Device Identifier (UDI)? 

A: Manufacturers or importers are required to include in their reports of corrections and 

removals the Unique Device Identifier (UDI) that appears on the device label or on the 

device package, or the device identifier, universal product code (UPC), model, catalog, or 

code number of the device and the manufacturing lot or serial number of the device or 

other identification number. 21 CFR 806.10(c)(5). We recommend the following format 

for submitting this information: 

1. If you are providing only UDI-DI, submit as “UDI-DI:” and the number. 

2. If you are providing full UDI, submit as “UDI:” and the number with all parentheses 

and special characters as provided. DO NOT include any blank spaces between 

characters within each UDI. 

3. If the recall impacts multiple models, then group UDI information by model. For 

example:

1 For additional information about what to include in a report of correction or removal, see 21 CFR 806.10(c); 

Product Recalls, Including Removals and Corrections (March 2020); CDRH Learn Recall module: 

https://www.fda.gov/files/medical%20devices/published/CDRHLearn--Recall-Module-21-CFR-Part-806--MedicalDevices--Reports-of-Corrections-and-Removals.pdf; CDRH Learn: Medical Device Recall videos and webinars, 

e.g.: Medical Device Recalls: Guidance for Industry (yorkcast.com).
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Product 1: (providing UDI-DI only)

UDI-DI: 00123456789012, Model A, Lot A213A1, Lot A213A2, Lot A213A3

UDI-DI: 00123456789013, Model B, Lot A213B1, Lot A213B2

UDI-DI: 00123456789014, Model C, Lot A213C1.

Product 2: (providing full UDIs)

UDI: (01)00123456789012(11)141231(17)150707(10)A213A1(21)1234, Model A, Lot A213A1

UDI: (01)00123456789012(11)141231(17)150707(10)A213A2(21)1235, Model A, Lot A213A2

UDI: (01)00123456789012(11)141231(17)150707(10)A213A3(21)1236, Model A, Lot A213A3, 

UDI: (01)00123456789013(11)141231(17)150707(10)A214B1(21)1236, Model B, Lot A213B1

UDI: (01)00123456789013(11)141231(17)150707(10)A214B2(21)1236, Model B, Lot A213B2

UDI: (01)00123456789014(11)141231(17)150707(10)A213C1(21)1236, Model C, Lot A213C1.

Long lists of impacted UDIs maybe submitted as an excel file, with separate columns for each 

data element you provide, grouped by UDI-DI as suggested above.

Q: Should I also submit labeling information? 

A: FDA recommends that you include labeling, which includes the individual package 

label and the directions for use, in your reports of corrections and removals.

Q: I have conducted a recall, should I also conduct an effectiveness check?

A: FDA recommends that you consider effectiveness checks for every recall. The 

purpose of effectiveness checks is to verify that all consignees at the recall depth 

specified by the firm’s recall strategy have received notification about the recall and have 

taken appropriate action (21 CFR 7.42(b)(3)).

Q: What are some methods to conduct recall effectiveness checks? 

A: In conducting a recall effectiveness check, there are certain basic questions that 

consignees should be asked. The purpose of these questions is to determine whether the 

recall notification was received, the product involved was handled as instructed in the 

recall notification (including whether the product was returned or corrected, including 

whether corrected in situ by reprogramming or upgrading software), the product was 

further distributed by the consignee before receipt of the recall notification, and if so, 

were these additional consignees notified. Other questions may need to be asked 

depending upon the nature of the recall.

The method for contacting consignees may be accomplished by personal visits, telephone 

calls, letters, or a combination thereof. Responses from consignees should be logged. 

Please note, “read receipts” indicating that an email containing a recall notification was 

opened or viewed, or certified delivery receipts indicating that a letter containing a recall 

notification was delivered, would not serve as confirmation that consignees have taken 

appropriate action in response to the recall notification.

2

2 Your effectiveness check is a means of evaluating the effectiveness of your recall. If your effectiveness checks 

indicate that the recall communication was not received and/or its instructions were not followed, then you should 

take steps to make the recall effective. These steps may involve using alternative means of contacting your 

customers or sending out a follow up communication that better identifies the product, better explains the problem 

and/or provides better instructions to the consignees.
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When the last of the recall effectiveness checks have been made, a final tabulation of the 

results of the contacts and questionnaires should be made. Evaluation of this data and the 

results of the recall should give an estimate of the effectiveness of the recall.

For more information about effectiveness checks, see 21 CFR 7.42(b)(3), the Methods for 

Conducting Recall Effectiveness Checks guide referred to in 21 CFR 7.42(b)(3),3 and 

section IV.1. of FDA’s Product Recalls, Including Removals and Corrections Guidance 

for Industry.

Q: How will my recall be evaluated?

A: You will be asked to provide Recall Status Reports to your FDA Division Recall 

Coordinator (DRC) after initiating a recall (usually on a monthly basis but more 

frequently when indicated). Your Recall Status Reports should usually include the 

following information: dates and method of customer notification; number of customers 

notified; number of customers that responded; quantity of recalled product returned or 

otherwise accounted for; number of customers that did not respond (FDA may ask for the 

identity of such customers); estimated time frame for completion of the recall; and details 

of your recall effectiveness checks. Because it is important to attempt to establish the root 

cause of a problem that results in a product recall so that appropriate corrective actions 

can be taken, we recommend that you also provide the root cause information to your 

DRC or appropriate Center contact. In addition, we also recommend that you explain to 

your DRC or appropriate Center contact the corrective and preventive actions planned or 

underway that will prevent a similar problem from recurring.4

Q: What should I submit to request termination of my recall?

A: 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 (see 21 CFR 7.55(a)). A recalling firm may request termination of 

its recall by submitting a written request stating that its recall is effective in accordance 

with the criteria set forth in 21 CFR 7.55(a), and by accompanying the request with the 

most current recall status report and a description of the disposition of the recalled 

product (see 21 CFR 7.55(b)).

3 Methods for Conducting Recall Effectiveness Checks is available upon request from the Division of Dockets 

Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 4 The quality system regulation requires that each manufacturer establish and maintain procedures for implementing 

corrective and preventive action, and that such procedures include requirements for, among other things, identifying 

the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, and 

verifying or validating the corrective and preventive action to ensure that such action is effective and does not 

adversely affect the finished device (21 CFR 820.100(a)(3), (4)).