ORA Recall Coordinators
FDA recall coordinators are now 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 team in the Office of Enforcement and Import Operations.
For any on-going recalls previously reported to your local recall coordinator, please continue to work with that recall coordinator.
For new recalls, use the table below to locate the recall coordinator assigned for your product type and location.
| Product Type | Firm's State | Recall Coordinator | Division |
|---|---|---|---|
| Medical Device | CT; DC; DE; IN; KY; MA; MD; ME; MI; NH; NJ; NY; OH; PA; RI; VA; VT; WV | Maria Caride Contact Division of Medical Device and Radiological Health Operations I 158-15 Liberty Avenue 4th Floor, Room 4013 Jamaica, NY 11433-1034 Phone: 718-662-5577 Fax: 718-662-5661 oradevices1recalls@fda.hhs.gov Melinda Ruiz Contact Division of Medical Device and Radiological Health Operations I 158-15 Liberty Avenue 4th Floor, Room 4013 Jamaica, NY 11433-1034 Phone: 718-662-5470 Fax: 718-662-5661 oradevices1recalls@fda.hhs.gov | Division of Medical Device and Radiological Health Operations I |
| Medical Device | AL; FL; GA; IA; IL; KS; LA; MN; MO; MS; NC; ND; NE; PR; SC; SD; TN; US Virgin Islands; WI | Neisa M Alonso Contact Division of Medical Device and Radiological Health Operations II 555 Winderley Place Suite 200 Maitland, FL 32751 Phone: 407-475-4717 Fax: 407-475-4769 oradevices2recalls@fda.hhs.gov Meredith Cobb Contact Division of Medical Device and Radiological Health Operations II 555 Winderley Place Suite 200 Maitland, FL 32751 Phone: 407-475-4722 Fax: 407-475-4769 oradevices2recalls@fda.hhs.gov Marie Fink Contact Division of Medical Device and Radiological Health Operations II US FDA Metairie Center 2424 Edenborn Avenue, Suite 410 Metairie, LA 70001 Phone: 504-846-6109 Fax: 504-219-8813 oradevices2recalls@fda.hhs.gov | Division of Medical Device and Radiological Health Operations II |
| Medical Device | AK; AR; AZ; CA; CO; HI; ID; MT; NM; NV; OK; OR; TX; UT; WA; WY | Neisa M Alonso Contact Division of Medical Device and Radiological Health Operations III 555 Winderley Place Suite 200 Maitland, FL 32751 Phone: 407-475-4717 Fax: 407-475-4769 oradevices3recalls@fda.hhs.gov Meredith Cobb Contact Division of Medical Device and Radiological Health Operations III 555 Winderley Place Suite 200 Maitland, FL 32751 Phone: 407-475-4722 Fax: 407-475-4769 oradevices3recalls@fda.hhs.gov Marie Fink Contact Division of Medical Device and Radiological Health Operations III US FDA Metairie Center 2424 Edenborn Avenue, Suite 410 Metairie, LA 70001 Phone: 504-846-6109 Fax: 504-219-8813 oradevices3recalls@fda.hhs.gov | Division of Medical Device and Radiological Health Operations III |
| Human and Animal Food & Cosmetics | CT; MA; ME; NH; NY; RI; VT | Susan Liner Contact Division of Human and Animal Food Operations East I One Montvale Avenue, 4th Floor Stoneham, MA 02180 Phone: 781-587-7481 Fax: 781-587-7556 orahafeast1recalls@fda.hhs.gov Pamela Ogonowski Contact Division of Human and Animal Food Operations East I One Montvale Avenue, 4th Floor Stoneham, MA 02180 Phone: 781-587-7449 Fax: 781-587-7556 orahafeast1recalls@fda.hhs.gov | Division of Human and Animal Food Operations East I |
| Human and Animal Food & Cosmetics | DC; DE; MD; NJ; PA; VA; WV | Ruark Lanham Contact Division of Human and Animal Food Operations East II 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Phone: 410-779-5414 Fax: 410-779-5705 orahafeast2recalls@fda.hhs.gov | Division of Human and Animal Food Operations East II |
| Human and Animal Food & Cosmetics | GA; NC; SC | Arnold Best Contact Division of Human and Animal Food Operations East III 60 Eighth Street, NE Atlanta, GA 30309 Phone: 404-253-1293 Fax: 404-253-1201 orahafeast3recalls@fda.hhs.gov | Division of Human and Animal Food Operations East III |
| Human and Animal Food & Cosmetics | FL; PR; US Virgin Islands | Wanda J. Torres Contact Division of Human and Animal Food Operations East IV 466 Fernandez Juncos Avenue San Juan, PR 00901-3223 Phone: 787-729-8709 Fax: 787-729-8826 orahafeast4recalls@fda.hhs.gov | Division of Human and Animal Food Operations East IV |
| Human and Animal Food & Cosmetics | AL; KY; LA; MS; OH; TN | Emma Nesbit Contact Division of Human and Animal Food Operations East V 6751 Steger Drive Cincinnati, OH 45237 Phone: 513-679-2700x2152 Fax: 513-679-2772 orahafeast5recalls@fda.hhs.gov | Division of Human and Animal Food Operations East V |
| Human and Animal Food & Cosmetics | IL; IN; MI | Michael Larson Contact Division of Human and Animal Food Operations East VI 300 River Place, Suite 5900 Detroit, MI 48207 Phone: 313-393-8118 Fax: 313-393-8139 orahafeast6recalls@fda.hhs.gov Victoria Murray Contact Division of Human and Animal Food Operations East VI 300 River Place, Suite 5900 Detroit, MI 48207 Phone: 313-393-8118 Fax: 313-393-8139 orahafeast6recalls@fda.hhs.gov | Division of Human and Animal Food Operations East VI |
| Human and Animal Food & Cosmetics | MN; ND; SD; WI | Kristine Zuroski Contact Division of Human and Animal Food Operations West I 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Phone: 612-758-7120 Fax: 612-334-4134 orahafwest1recalls@fda.hhs.gov | Division of Human and Animal Food Operations West I |
| Human and Animal Food & Cosmetics | IA; KS; MO; NE | Matthew Sleeter Contact Division of Human and Animal Food Operations West II 8050 Marshall Drive Suite 205 Lenexa, KS 66214 Phone: 913-495-5151 Fax: 913-495-5105 orahafwest2recalls@fda.hhs.gov | Division of Human and Animal Food Operations West II |
| Human and Animal Food & Cosmetics | AR; OK; TX | Casey Hamblin Contact Division of Human and Animal Food Operations West III 4040 N. Central Expressway Suite 300 Dallas, TX 75204 Phone: 214-253-5222 Fax: 214-253-5314 orahafwest3recalls@fda.hhs.gov | Division of Human and Animal Food Operations West III |
| Human and Animal Food & Cosmetics | AZ; CO; NM; UT; WY | Caroline Le Contact Division of Human and Animal Food Operations West IV Building 20, Denver Federal Center 6th Avenue & Kipling Street PO Box 25087 Denver, CO 80225-0087 Phone: 303-236-3045 Fax: 303-236-3551 orahafwest4recalls@fda.hhs.gov | Division of Human and Animal Food Operations West IV |
| Human and Animal Food & Cosmetics | CA; HI; NV | Marjorie Schultz Contact Division of Human and Animal Food Operations West V 1431 Harbor Bay Parkway Alameda, CA 94502 Phone: 510-337-6898 Fax: 510-337-6705 orahafwest5recalls@fda.hhs.gov | Division of Human and Animal Food Operations West V |
| Human and Animal Food & Cosmetics | AK; ID; MT; OR; WA | Ahn Trinh Nguyen Contact Division of Human and Animal Food Operations West VI 22215 26th Ave. SE, Suite 210 Bothell, WA 98021 Phone: 425-302-0467 Fax: 425-302-0403 orahafwest6recalls@fda.hhs.gov | Division of Human and Animal Food Operations West VI |
| Biologics | All U.S. | Thanh B Tran Contact Division of Biological Products Operations I 19701 Fairchild Irvine, CA 92612 Phone: 949-608-3504 Fax: 949-608-4401 biologicsrecalls@fda.hhs.gov | Division of Biological Products Operations I |
| Pharmaceutical | CT; DC; DE; MA; MD; ME; NH; NJ; NY; PA; RI; VA; VT; WV | Lisa Mathew Contact Division of Pharmaceutical Quality Operations I 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Phone: 973-331-4917 Fax: 973-331-4969 orapharm1recalls@fda.hhs.gov Dellarese Herbert Contact Division of Pharmaceutical Quality Operations I 900 US Customhouse Suite 904 200 Chestnut Street Philadelphia, PA 19106 Phone: 215-717-3747 Fax: 215-517-6649 orapharm1recalls@fda.hhs.gov | Division of Pharmaceutical Quality Operations I |
| Pharmaceutical | AL; AR; FL; GA; LA; MS; NC; OK; PR; SC; TN; TX; US Virgin Islands | Kenitra Hewitt Contact Division of Pharmaceutical Quality Operations II 501 West Felix Street Suite 1103 Fort Worth, TX 76115 Phone: 817-334-5218 Ext. 1104 Fax: 817-334-5642 orapharm2recalls@fda.hhs.gov | Division of Pharmaceutical Quality Operations II |
| Pharmaceutical | IA; IL; IN; KY; KS; MI; MN; MO; ND; NE; OH; SD; WI | Mennie EldridgeContact Division of Pharmaceutical Quality Operations III 550 West Jackson Blvd., #1625 Chicago, IL 60661 Phone: 312-596-4239 Fax: 312-596-4125 orapharm3recalls@fda.hhs.gov | Division of Pharmaceutical Quality Operations III |
| Pharmaceutical | AK; AZ; CA; CO; HI; ID; MT; NM; NV; OR; UT; WA; WY | Lisa Mathew Contact Division of Pharmaceutical Quality Operations IV 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Phone: 973-331-4917 Fax: 973-331-4969 orapharm4recalls@fda.hhs.gov Dellarese Herbert Contact Division of Pharmaceutical Quality Operations IV 900 US Customhouse Suite 904 200 Chestnut Street Philadelphia, PA 19106 Phone: 215-717-3747 Fax: 215-517-6649 orapharm4recalls@fda.hhs.gov | Division of Pharmaceutical Quality Operations IV |
| Tobacco | 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; | Cecilia M. Wolyniak Contact Tobacco Operations WO 32 RM 4352 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-8209 Fax: 301-847-8635 oratobaccorecalls@fda.hhs.gov | Tobacco Operations |
ORA Headquarters
For general recall inquiries, including guidance for foreign firms recalling products exported to the USA
Cecilia M. Wolyniak
ORA
Office of Enforcement and Import Operations
Recall Branch
WO 32 RM 4352
10903 New Hampshire Ave.
Silver Spring, MD 20993
Phone: 301-796-8209
Fax: 301-847-8635
orahqroe@fda.hhs.gov