Medical Device Recall Letter Template: 21 CFR 7.49

This page describes products and general use; it is not medical advice, and it is not legal advice.

A medical device recall letter is the notice a recalling firm sends to its affected direct accounts. Under FDA’s recall policy in 21 CFR 7.49 it must tell the recipient that the product is subject to a recall, that further distribution or use of any remaining product should cease immediately, and what to do with the product. FDA also publishes a model recall notification letter for devices; the template below follows its order and ties each part to the regulation text.

Who uses it: regulatory and quality staff at manufacturers and distributors who draft recall letters, and clinic, hospital and laboratory staff who receive them and must act on them. For the wider picture of recalls, corrections and removals, see medical device recall and field safety corrective action (FSCA), which covers the EU field safety notice.

What a recall letter must say

21 CFR 7.49(a) says the format, content and extent of a recall communication should be commensurate with the hazard of the product and the recall strategy. The table maps each element to its source.

Element	What the source says	Source
Recall statement	Convey that the product is subject to a recall	21 CFR 7.49(a)(1)
Stop use	Further distribution or use of any remaining product should cease immediately	21 CFR 7.49(a)(2)
Downstream notice	Where appropriate, the direct account should in turn notify its customers who received the product	21 CFR 7.49(a)(3)
Instructions	Provide specific instructions on what should be done with the recalled products	21 CFR 7.49(a)(4), (c)(1)(iv)
Product identification	Identify the product, size, lot numbers, codes or serial numbers and other descriptive information for accurate and immediate identification	21 CFR 7.49(c)(1)(ii)
Reason and hazard	Explain concisely the reason for the recall and the hazard involved, if any	21 CFR 7.49(c)(1)(iii)
Brevity	Be brief and to the point	21 CFR 7.49(c)(1)(i)
Reply route	Provide a ready means for the recipient to report whether it has any of the product, for example a postage-paid, self-addressed postcard	21 CFR 7.49(c)(1)(v)

Template structure in FDA model-letter order

FDA’s Medical Device Model Recall Notification Letter uses the sections below. Placeholders are in square brackets; replace them with your own recall facts.

Title block. “URGENT: MEDICAL DEVICE RECALL”, the date, the recipient’s address and an attention line.
Purpose. The model wording is: “The purpose of this letter is to advise you that [Company Name] is voluntarily recalling [Product X].”
Reason for the recall. The model asks the firm to identify the product concerns or problems, actual or potential, in detail, including failure frequency and adverse events.
Risk to health. How failure affects patients or providers, and how to recognize that the device may fail.
Actions for the customer. Actions for safe handling of the recalled product, interim steps, replacement, and acknowledging receipt.
Product and distribution information. A table of product names, identifiers, lot numbers, dates and quantities.
What the firm is doing. The model asks “What is the firm doing to correct this issue?” and gives a timeline.
Contact information. Plus a note that adverse events or quality problems can be reported to FDA MedWatch.
Return response form. Headed “MEDICAL DEVICE RECALL RETURN RESPONSE”, marked “Response is Required”, covering acknowledgment, adverse events, implants and inventory.

Marking and delivery

21 CFR 7.49(b) says a recall communication can be made by telegrams, mailgrams or first class letters conspicuously marked, preferably in bold red type, on the letter and the envelope, with the words “recall” or “correction” for the product type. The letter and envelope should also be 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 those methods or documented in an appropriate manner. FDA’s recalls page for devices likewise says the letter and envelope should be marked “urgent” for class I and class II recalls.

Product and distribution table

The model letter’s product table is where recipients match their stock against the notice. Columns follow the model: product name, identifier (catalog or model, serial or code), lot number, dates, and quantity. Section 7.49(c)(1)(ii) is the underlying requirement: enough descriptive detail for accurate and immediate identification. For how lot and code fields are laid out on labels, see how to read a lot number.

Response form

The response form is the “ready means” required by 7.49(c)(1)(v). In the FDA model it asks the recipient to acknowledge the notice and report adverse events, implants and inventory. 7.49(c)(2) adds that where necessary, follow-up communications should be sent to those who fail to respond to the initial communication.

Recall classes and urgency

FDA’s recalls page for devices defines the classes by the health consequence of using the product.

Class	FDA definition
Class I	Reasonable probability of serious adverse health consequences or death
Class II	Temporary or medically reversible adverse health consequences
Class III	Not likely to cause adverse health consequences

See class III recall for the lowest class, and FDA enforcement reports for where classified recalls are listed.

Who sends it and when to talk to FDA first

The recalling firm is responsible for promptly notifying each affected direct account. FDA’s recalls page says the firm is encouraged to discuss the recall letter with its FDA Division of Recall Coordinators (DRC) before issuing the notification, and says to be brief and to the point and to explain concisely the reason for the recall and the hazard. Manufacturers and importers must report a correction or removal that involves a risk to health to FDA within 10 working days; see 21 CFR Part 806 and 21 CFR Part 7 recalls.

Recipient checklist

21 CFR 7.49(d) says consignees that receive a recall communication should immediately carry out the instructions in it and, where necessary, extend the recall to their own consignees. A practical reading of that duty:

Check the product table against what you hold: product, size, lot or serial numbers, codes.
Note whether the letter tells you to cease distribution or use of remaining product, as 7.49(a)(2) provides for.
Carry out the letter’s instructions for the product, as 7.49(d) provides.
Return the response form to the recalling firm, including when you hold none of the product.
If you supplied the product to others, notify them where the letter calls for it.
Report adverse events as the letter and FDA MedWatch direct.

The checklist is an editorial summary of 7.49(d) and the model response form, not a substitute for the letter you receive.

Common mistakes the rule warns against

Burying the message. 7.49(c)(2) says the communication should not contain irrelevant qualifications, promotional materials or any other statement that may detract from the message.
Vague identification. Without lot, code or serial detail, recipients cannot tell whether they hold affected product.
No reply route. The letter needs a way for recipients to report whether they have the product.
No follow-up. Non-responders should be followed up where necessary.
Unconfirmed phone calls. Telephone contacts should be confirmed in writing or documented.

For an example of a recall that recipients had to check against their own stock, see glucose meter recall; for the corrective-action process behind a recall, see CAPA and FDA.

FAQ

Does FDA provide a model medical device recall letter?

Yes. FDA publishes a Medical Device Model Recall Notification Letter as a Word document, with a return response form. The structure above follows it.

What is the difference between a recall letter and a field safety notice?

Both notify customers of a safety action. A field safety notice is the EU term used with a field safety corrective action; the FSCA guide sets out the cross-walk.

How should a recall letter be marked?

Per 21 CFR 7.49(b): conspicuously, preferably in bold red type, with “recall” or “correction” wording, and “urgent” for class I and class II recalls.

Sources

21 CFR 7.49, Recall communications, law.cornell.edu/cfr/text/21/7.49 (checked 2026-11-01); also at eCFR.
FDA, Medical Device Model Recall Notification Letter, fda.gov/media/84668/download (checked 2026-11-01).
FDA, Recalls, Corrections and Removals (Devices), fda.gov (checked 2026-11-01).

Medical Device Recall Letter Template: Required Elements and Annotated Structure