Free public-record lookup
Search FDA Registration, Recall, Inspection & Warning-Letter Records
Search U.S. medical-device facilities and companies for their FDA registration, the devices they make, and recall history — sourced from openFDA.
2,799 device facilities and 1,181 companies with FDA recall history · data as of 2026-10-29
Latest FDA actions
- Warning letterEmerge Technologies Inc (opens in a new tab) Texas
- Inspection VAIMedical Instrument Development Laboratories, Inc. (opens in a new tab)
- Inspection VAISurgical Instrument Manufacturers, LLC (opens in a new tab)
- Inspection VAIPost Oak Innovations, Inc. (opens in a new tab)
- Warning letterGyrus ACMI, Inc. (opens in a new tab) Minnesota
- Warning letterOLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant (opens in a new tab)
- Warning letterShirakawa Olympus Co., Ltd. (opens in a new tab)
- Warning letterAOMORI OLYMPUS CO., LTD. Kuroishi Site (opens in a new tab)
- Warning letterOlympus Corporation of the Americas (opens in a new tab) Pennsylvania
- Warning letterOlympus Winter & IBE Gmbh (opens in a new tab)
- Warning letterOlympus Medical Systems Corporation (opens in a new tab)
- Warning letterPro-Optics LLC (opens in a new tab) Illinois
- Warning letterChirp Innovation, LLC (opens in a new tab) Utah
- Inspection VAIJazz Imaging (opens in a new tab)
- Class IIIntegrated Medcraft LLC
- Inspection VAIPrimo Passi (opens in a new tab)
- Inspection VAITrax Surgical, Inc. (opens in a new tab)
- Inspection VAIEnviropak, LLC (opens in a new tab)
- Class IISTERIS Corporation
- Inspection VAIViscus Biologics LLC (opens in a new tab)
- Class IISTERIS Corporation
- Inspection VAIControl Bionics (opens in a new tab)
- Inspection VAIGrimm Scientific Industries (opens in a new tab)
- Class IIHowmedica Osteonics Corp.
- Class IICOOK, INC.
- Class IIBAXTER HEALTHCARE CORPORATION
- Class IINOxBOX Limited
- Class IIMedline Industries, LP
- Class IIBoston Scientific Corporation
- Class IIIn2Bones USA, LLC
Class I/II/III is FDA’s recall classification; OAI/VAI is FDA’s inspection classification. Warning-letter links open an FDA search (FDA can take several weeks to post a letter); inspection links open the FDA Data Dashboard profile, which can take several seconds to load. All recent recalls
Recently updated facilities
- INTEGRATED MEDCRAFT LLC CT
- Key Surgical, LLC MN
- Cook Incorporated IN
- Cook Incorporated IN
- COOK INCORPORATED IN
- Cook Incorporated IL
- COOK, INC. IN
- WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V. MX
- Baxter Healthcare of Puerto Rico LLC PR
- SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) MN
- BAXTER HEALTHCARE CORPORATION IL
- Baxter Limited MT
Companies with recent recalls
- Integrated Medcraft LLC 2 recall(s)
- STERIS Corporation 61 recall(s)
- COOK, INC. 78 recall(s)
- BAXTER HEALTHCARE CORPORATION 211 recall(s)
- NOxBOX Limited 6 recall(s)
- Medline Industries, LP 242 recall(s)
- Boston Scientific Corporation 188 recall(s)
- In2Bones USA, LLC 5 recall(s)
- ETHICON INC. 37 recall(s)
- NIHON KOHDEN CORP. 10 recall(s)
- Intelerad Medical Systems Incorporated 4 recall(s)
- MAGELLAN Diagnostics INC. 10 recall(s)