Recall Communication: 

Medical Device Model RNotification Letter 

Ronny BrownActing Chief, Recall BranchDivision of Risk Management OperationsU.S. Food and Drug AdministrationCenter for Devices and Radiological Health
Company Recall Requiremen

 The recalling company is responsible fo

notifying each of its affected direct accodistributors, contractors, customers) ab

 A recall communication can be in the fo

release, telephone call, telegram, mailclass letter. It is highly recommended thfirm discuss a recall letter with the FDA recall coordinator prior to issuing the no

www.fda.gov/MedicalDevices/Saf

www.fda.gov/MedicalDevices/Saf

RecallsCorrectionsRemovals/ucm243

www.fda.gov/MedicalDevices/De www.fda.gov/MedicalDevices/DeviceRegulation

viceRegulation

PostmarketRequirements/RecallsCorrectionsAndRe
What is the reason for the com

notification? To provide details regarding the p

recall

 To supply information to help use

the product

 To minimize health consequence

providing instructions on what acto be taken

www.fda.gov/MedicalDevices/S

www.fda.gov/MedicalDevices/S

RecallsCorrectionsRemovals/ucm24

RecallsCorrectionsRemovals/ucm24
Recall Notification

 First Class Letter should be conspicuous

preferably in bold red type, on the letter envelope: “URGENT Medical Device Re

 The letter and the envelope should be al

“URGENT" for Class I and Class II recalappropriate, for Class III recalls. 

 Telephone calls or other personal contac

confirmed by one of the above methods documented in an appropriate manner.

www.fda.gov/MedicalDevices/DeviceRegulatio

www.fda.gov/MedicalDevices/DeviceRegulatio

PostmarketRequirements/RecallsCorrectionsAndR
Recall Notification Letter
Recall Notification T
Recall Notification Le
Recall Notification Greeting & 
Recall Notification Le
Recall Notification Footnot

 1Recommended for Class I and II recalls. 

should be noted on both the letter and en21 CFR 7.49(4)(b).

 2 For radiation-emitting electronic product

action is governed by 21 CFR 1004 – ReRepairs, or Replacement of Electronic Prwhich manufacturers are required to bring into conformity with applicable performancorrect any reported device defect at no cuser. Medical device recalls are governe806 – Reports of Corrections and Removdoes not contain an equivalent requireme
Recall Notification Le
Recall Notification Lette

Risk to Health and Action to b
Recall Notification L
Recall Notification Letter –

Product Distribution and Action by C
Recall Notification L
Recall Notification Let

Other Information
Recall Notification Forma

 The format, content, and extent o

notification should be commensurecall hazard and strategy. 
Sample Acknowledgemen
Inappropriate Information

in a Recall Notification Qualification data Promotional materials  Any other statement that may 

from the message
Notification Follow-up

 When necessary, additional com

should be sent to customers who acknowledge receiving the initial 
Consignee/Distributor Respon

 Upon receipt of a recall notificatio

instructions set forth by the recall

 When necessary, extend the reca

customers in accordance with the provided by the firm.
Conclusion

 Notification letters must provide clear 

regarding the issue and the health risk 

 Information identifying affected produc

easy to find.

 Actions to be taken by the users shou

or numbered to clearly articulate the reminimize risk or impact of affected pro

 Notification should be sectioned to allo

quickly see the information needed to recall requirements.
Thank You

 If you have further questions rega

reporting requirements, contact:

Your local FDA District Recall Coo

http:// http://www.fda.gov www.fda.gov/Safety/R

/Safety/R

IndustryGuidance/ucm1293

IndustryGuidance/ucm1293

CDRH’s Division of Small Manufacturer

and Consumer Assistance (DSM

1-800-638-2041, 301-796-710

dsmica@ fda.hhs.gov fda.hhs.gov
http://www.fda.gov/Safety/R

IndustryGuidance/ucm1293

dsmica@ fda.hhs.gov

Thank You

 If you have further questions rega

reporting requirements, contact:

Your local FDA District Recall Coo

http://www.fda.gov/Safety/R

IndustryGuidance/ucm1293

CDRH’s Division of Small Manufacturer

and Consumer Assistance (DSM

1-800-638-2041, 301-796-710

dsmica@ fda.hhs.gov