ORA Recall Coordinators

FDA recall coordinators are aligned in program-based divisions: Division of Medical Devices and Radiological Health, Division of Human and Animal Food Operations (includes cosmetics), Division of Biological Products, Division of Pharmaceutical Quality Operations and Tobacco Operations. Establishments outside the United States should continue to contact the recall branch in the Office of Strategic Planning and Operational Policy.

For new recalls, use the table below to locate the recall coordinator assigned for your product type and location. Drug and device firms located outside the United States should report their recall to the Recall Coordinator in the state where your U.S. Agent is located.

Product Type	Division	Firm's State	Recall Coordinator
Medical Device	Division of Medical Device and Radiological Health Operations I	CT; DC; DE; IN; KY; MA; MD; ME; MI; NH; NJ; NY; OH; PA; RI; VA; VT; WV	Andrew LangContact 6751 Steger Drive Cincinnati, OH 45237 P: 513-679-2700 x2177 F: 513-679-2773 oradevices1recalls@fda.hhs.gov Emma Schaefer Contact 101 W. Broad St. Suite 400 Falls Church, VA 22046 Phone: 813-915-7968 oradevices1recalls@fda.hhs.gov Cynthia Aycock Contact 300 River Place Dr. Ste. 5900 Detroit, MI 48207 P: 313-393-8162 F: 313-393-8139 oradevices1recalls@fda.hhs.gov Teresa Kastner Contact 550 Main St. Cincinnati, OH 45202 Phone: 513-322-0634 Fax: 407-475-4769 oradevices1recalls@fda.hhs.gov
Medical Device	Division of Medical Device and Radiological Health Operations II	AL; FL; GA; IA; IL; KS; LA; MN; MO; MS; NC; ND; NE; PR; SC; SD; TN; US Virgin Islands; WI	Meredith AndressContact 4121 Carmichael Rd Suite 307 Montgomery, AL 36106 Phone: 334-273-4788 ext. 106 Fax: 334-273-4790 oradevices2recalls@fda.hhs.gov Marie Fink Contact US FDA Metairie Center 2424 Edenborn Avenue, Suite 410 Metairie, LA 70001 Phone: 504-846-6109 Fax: 504-219-8813 oradevices2recalls@fda.hhs.gov
Medical Device	Division of Medical Device and Radiological Health Operations III	AK; AR; AZ; CA; CO; HI; ID; MT; NM; NV; OK; OR; TX; UT; WA; WY	Mark ChanContact 96 North Third Street, Room 420 San Jose, CA 95112 Phone: 408-291-7548 x 1108 Fax: 408-291-7228 oradevices3recalls@fda.hhs.gov Theresa Kirkham Contact 19701 Fairchild Irvine, CA 92612 Phone: 949-608-4437 Fax: 949-608-4498 oradevices3recalls@fda.hhs.gov Paul Frazier Contact 4040 N. Central Expressway, Suite 300 Dallas, TX 75204 Phone: 214-253-5340 Fax: 214-253-5314 oradevices3recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations East I	CT; MA; ME; NH; NY; RI; VT	Randi-Lynn Bodoh Contact Syracuse Resident Post 620 Erie Blvd., West Syracuse, NY 13205 Phone: 315-448-0876 x 1011 orahafeast1recalls@fda.hhs.gov Acting Recall Coordinator Contact orahafeast1recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations East II	DC; DE; MD; NJ; PA; VA; WV	Ruark Lanham Contact 900 US Customhouse, Suite 904 200 Chestnut Street Philadelphia, PA 19106 Phone: 215-717-3738 Fax: 215-517-6649 orahafeast2recalls@fda.hhs.gov Nina Patel Contact 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Phone: 410-779-5132 orahafeast2recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations East III	GA; NC; SC	Emma NesbitContact 60 Eighth Street, NE Atlanta, GA 30309 Phone: 404-253-1224 Fax: 404-253-1201 orahafeast3recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations East IV	FL; PR; US Virgin Islands	Beira Montalvo Contact 1515 N Federal Hwy Suite 111 Boca Raton, FL 33432 Phone: 301-837-4617 Fax: 787-729-8826 orahafeast4recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations East V	AL; KY; LA; MS; OH; TN	Caitlin Almonrode Contact 404 BNA Drive, Suite 500 Nashville, TN 37217 Phone: 615-366-7859 orahafeast5recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations East VI	IL; IN; MI	Michael Larson Contact 300 River Place, Suite 5900 Detroit, MI 48207 Phone: 313-393-8118 Fax: 313-393-8139 orahafeast6recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations West I	MN; ND; SD; WI	Kristine Zuroski Contact 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Phone: 612-758-7120 Fax: 612-334-4134 orahafwest1recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations West II	IA; KS; MO; NE	Shannon Hall Contact 8050 Marshall Drive Suite 205 Lenexa, KS 66214 Phone: 913-495-5160 Fax: 913-495-5105 orahafwest2recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations West III	AR; OK; TX	Brandi Williams Contact 4040 N. Central Expressway Suite 300 Dallas, TX 75204 Phone: 301-837-4769 Fax: 501-324-5080 orahafwest3recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations West IV	AZ; CO; NM; UT; WY	Jamie Port Contact Building 20, Denver Federal Center 6th Avenue & Kipling Street PO Box 25087 Denver, CO 80225-0087 Phone: 808-404-4628 Fax: 303-236-3551 orahafwest4recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations West V	CA; HI; NV	Vacant Contact 1201 Harbor Bay Parkway Alameda, CA 94502 Phone: 510-337-6898 Fax: 510-337-6705 orahafwest5recalls@fda.hhs.gov
Human and Animal Food & Cosmetics	Division of Human and Animal Food Operations West VI	AK; ID; MT; OR; WA	Anh Trinh NguyenContact 22215 26th Ave. SE, Suite 210 Bothell, WA 98021 Phone: 425-302-0467 Fax: 425-302-0403 orahafwest6recalls@fda.hhs.gov
Biologics	Division of Biological Products Operations I	All U.S. AL; AK; AZ; AR; CA; CO; CT; DC; DE; FL; GA; HI; ID; IL; IN; IA; KS; KY; LA; ME; MD; MA; MI; MN; MS; MO; MT; NE; NV; NH; NJ; NM; NY; NC; ND; OH; OK; OR; PA; RI; SC; SD; TN; TX; UT; VT; VA; WA; WV; WI; WY; AS; DC; FM; GU; MH; MP; PW; PR; VI; US Virgin Islands;	Thanh B TranContact 19701 Fairchild Irvine, CA 92612 Phone: 949-608-3504 Fax: 949-608-4401 biologicsrecalls@fda.hhs.gov
Pharmaceutical	Division of Pharmaceutical Quality Operations I	CT; DC; DE; MA; MD; ME; NH; NJ; NY; PA; RI; VA; VT; WV	Lisa Mathew Contact 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Phone: 973-331-4917 Fax: 973-331-4969 orapharm1recalls@fda.hhs.gov Dellarese Priester Contact 60 8th Street NE Suite 102 Atlanta, GA 30309 Phone: 215-717-3747 orapharm1recalls@fda.hhs.gov
Pharmaceutical	Division of Pharmaceutical Quality Operations II	AL; AR; FL; GA; LA; MS; NC; OK; PR; SC; TN; TX; US Virgin Islands	Erma Zaimova Contact 678 Front Ave NW, Unit 225 Grand Rapids, MI 49504 Phone: 301-837-4497 orapharm2recalls@fda.hhs.gov
Pharmaceutical	Division of Pharmaceutical Quality Operations III	IA; IL; IN; KY; KS; MI; MN; MO; ND; NE; OH; SD; WI	Mennie ThompsonContact 550 West Jackson Blvd., #1625 Chicago, IL 60661 Phone: 312-596-4239 Fax: 312-596-4125 orapharm3recalls@fda.hhs.gov
Pharmaceutical	Division of Pharmaceutical Quality Operations IV	AK; AZ; CA; CO; HI; ID; MT; NM; NV; OR; UT; WA; WY	Farhana KhanContact 22215 26th Ave. SE Suite 210 Bothell, WA 98021 Phone: 425-302-0361 orapharm4recalls@fda.hhs.gov
Tobacco	Tobacco Operations	All U.S. AL; AK; AZ; AR; CA; CO; CT; DC; DE; FL; GA; HI; ID; IL; IN; IA; KS; KY; LA; ME; MD; MA; MI; MN; MS; MO; MT; NE; NV; NH; NJ; NM; NY; NC; ND; OH; OK; OR; PA; RI; SC; SD; TN; TX; UT; VT; VA; WA; WV; WI; WY; AS; DC; FM; GU; MH; MP; PW; PR; VI; US Virgin Islands;	LCDR Mouhamed HalwaniContact WO 32 RM 4352 10903 New Hampshire Ave. Silver Spring, MD 20993 oratobaccorecalls@fda.hhs.gov

ORA Headquarters

For general recall inquiries, including guidance for foreign firms recalling products exported to the USA and FDA's 3rd party contract for Recall Audit Checks:

LCDR Mouhamed Halwani
Branch Chief

ORA Office of Policy Compliance & Enforcement
Recall Operations Branch (OPCE ROB)
orarecalloe@fda.hhs.gov

If a physical mailing address is required to transmit documents to OPCE ROB, please contact us at orarecalloe@fda.hhs.gov.