FDA Recall Coordinator: Who They Are, How to Find Yours and What to Send

Short answer: An FDA recall coordinator is the FDA staff contact a firm reports a new recall to. FDA assigns coordinators by product type and by the firm’s location, and a lookup table and an address-and-commodity search tool are published on FDA’s “OII Recall Coordinators” page (checked 1 November 2026). Firms outside the United States report to the coordinator for the state where their U.S. Agent is located.

This guide is general regulatory information, not legal or medical advice. It is written for lab, clinic and supply staff who need to know who the coordinator is, how a firm reaches one, and how that differs from the recall notice a buyer receives.

Definition and scope

FDA’s page states that “FDA recall coordinators are aligned in program-based inspectorates”: Medical Products (medical devices and radiological health), Food Products (human food, animal food and cosmetics), Biological Products, and separate operations for human and animal drugs and for tobacco. A recall, in FDA’s wording, is an action taken by a firm to remove a product from the market, and it starts on the firm’s own initiative, by FDA request, or by FDA order under statutory authority (FDA, Recalls Background and Definitions, checked 1 November 2026). That page defines the three recall classes and market withdrawals; for the classes themselves see Class I vs II vs III recalls.

The coordinator is therefore the firm-facing point of contact. A laboratory or clinic that bought an affected product normally never contacts the coordinator; it receives a notice from the manufacturer or distributor.

How to find your FDA recall coordinator

FDA tells firms: “For new recalls, use the table below to locate the recall coordinator assigned for your product type and location.” The same page offers a “Find Your FDA Recall Coordinator Application” that searches by address and commodity. Two routing rules follow from the page:

• Product type first. FDA groups coordinators by program: medical products, food products, biological products, human and animal drugs, and tobacco.
• Then location. For devices, the contacts are split across four regional inspectorates, shown below.
• Firms outside the United States. Drug and device firms located outside the United States report to the coordinator in the state where their U.S. Agent is located. General questions, including those from foreign firms recalling products exported to the United States, go to the OII headquarters recall mailbox listed on the page.

Medical device coordinators by region

FDA’s page splits device recall coordinators across four regional inspectorates. States and territories as listed on the page when checked on 1 November 2026:

Device inspectorate	States and territories covered
I / West	AK, AZ, CA, CO, HI, ID, NM, NV, OR, UT, WA, Guam, Northern Mariana Islands, American Samoa
II / South	AL, AR, FL, GA, LA, MS, NC, OK, PR, SC, TN, TX, Virgin Islands
III / Northeast	CT, DC, DE, KY, MA, MD, ME, NH, NJ, NY, PA, RI, VA, VT, WV
IV / Midwest	IA, IL, IN, KS, MI, MN, MO, MT, ND, NE, OH, SD, WI, WY

Named individuals and phone numbers on the page change, so this guide points to the live table instead of copying them.

What a firm provides under 21 CFR 7.46

When a firm decides on its own to remove or correct a distributed product, 21 CFR 7.46 says a firm that believes the product is violative “is requested to notify immediately the appropriate Food and Drug Administration district office” (21 CFR 7.46, Cornell LII mirror, checked 1 November 2026). The regulation refers to district offices listed in 21 CFR 5.115; FDA’s current coordinator page is the lookup for who handles a new recall by product and location. The regulation lists the information FDA will ask the firm to provide, which works as a preparation checklist:

1. Identity of the product
2. Reason for the removal or correction, and the date and circumstances in which the problem was discovered
3. Evaluation of the risk associated with the problem
4. Total amount of product produced, and the timespan of production
5. Total amount of product estimated to be in distribution
6. Distribution information, including the number of direct accounts and, where necessary, their identity
7. A copy of the firm’s recall communication, or the proposed communication
8. The firm’s proposed strategy for the recall
9. Name and telephone number of the firm official to contact about the recall

Coordinator versus the notice you receive

These are two different relationships. The table separates them.

Question	Firm that is recalling	Lab, clinic or supply buyer
Who is the FDA contact?	The recall coordinator for the product type and location	Usually none; the recall communication comes from the firm
What is handed over?	The 21 CFR 7.46 information above	Your own records of what you hold
Where to look?	FDA’s OII Recall Coordinators page	Your supplier file and the lot or serial numbers on stock

If a notice arrives, the practical checks are on existing CASRAI pages: how to read a lot number to match stock to the notice, FDA enforcement reports for the published record of recalls, medical device recalls, medical device tracking requirements, and vendor documentation for what to keep on file for each supplier.

Common misunderstandings

“Recall coordinators” are not one national office

FDA’s page lists multiple coordinators, assigned by product type and location, plus a separate headquarters mailbox for general inquiries.

A coordinator is not the same as FDA’s classification of a recall

Classes I, II and III describe the health hazard of the product, as defined on FDA’s Recalls Background and Definitions page. They are not a title or a contact.

A firm’s removal is not always a “recall”

21 CFR 7.46 says a removal or correction is considered a recall only if FDA regards the product as involving a violation subject to legal action, for example seizure. A firm that believes its removal is a market withdrawal is told to consult the appropriate district office when the reason is not obvious.

FAQ

What is an FDA recall coordinator?

The FDA staff contact assigned to receive and handle a firm’s new recall, aligned by product program (devices, drugs, biologics, food, tobacco) and assigned by product type and location, according to FDA’s OII Recall Coordinators page.

How do I find the right FDA recall coordinator?

Use the table on FDA’s OII Recall Coordinators page for your product type and state, or the “Find Your FDA Recall Coordinator Application,” which searches by address and commodity.

Do foreign firms report to a coordinator?

Drug and device firms outside the United States report to the recall coordinator in the state where their U.S. Agent is located. General inquiries from foreign firms go to the OII headquarters mailbox on the same page.

Who starts a recall?

FDA says a recall starts on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.

Sources

• FDA, OII Recall Coordinators, checked 1 November 2026.
• FDA, Recalls Background and Definitions, checked 1 November 2026.
• 21 CFR 7.46, Firm-initiated recall (Cornell LII), checked 1 November 2026.