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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.
2,806 device facilities and 1,177 companies with FDA recall history · data as of 2026-10-14
Latest FDA actions
- Warning letterOlympus Medical Systems Corporation (opens in a new tab)
- Warning letterGyrus ACMI, Inc. (opens in a new tab) Minnesota
- Warning letterAOMORI OLYMPUS CO., LTD. Kuroishi Site (opens in a new tab)
- Warning letterShirakawa Olympus Co., Ltd. (opens in a new tab)
- Warning letterOlympus Winter & IBE Gmbh (opens in a new tab)
- Warning letterOlympus Corporation of the Americas (opens in a new tab) Pennsylvania
- Warning letterOLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant (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 VAIPrimo Passi (opens in a new tab)
- Inspection VAITrax Surgical, Inc. (opens in a new tab)
- Inspection VAIViscus Biologics LLC (opens in a new tab)
- Inspection VAIControl Bionics (opens in a new tab)
- Inspection VAIFriendship Industries Inc. (opens in a new tab)
- Inspection VAIRLS Interventional, Inc. (opens in a new tab)
- Inspection VAIMaymom LLC (opens in a new tab)
- Inspection VAIHeartbeam (opens in a new tab)
- Inspection VAIM.A.C. Medical Inc. (opens in a new tab)
- Class IINOxBOX Limited
- Inspection VAIPrecision Medical Technologies (opens in a new tab)
- Class IDraeger, Inc.
- Warning letterO.N. Diagnostics, LLC (opens in a new tab) California
- Class IIPhilips North America
- Class IIOlympus Corporation of the Americas
- Class IIASP Global, LLC
- Class IIOlympus Corporation of the Americas
- Class IBoston Scientific Corporation
- Class IIMIDMARK CORP.
- Class IIPhilips North America Llc
- Class IIAlere San Diego, Inc.
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
- NOXBOX LIMITED GB
- DRAEGER, INC. TX
- Boston Scientific Medical Device (Malaysia) SDN BHD MY
- INTERA ONCOLOGY MA
- BOSTON SCIENTIFIC CORPORATION MN
- Boston Scientific Limited IE
- BOSTON SCIENTIFIC CORPORATION MA
- GALIL MEDICAL LTD. IL
- Boston Scientific Corporation CR
- Boston Scientific Corp., Marina Bay Cust. Fulfillment Center MA
- ASP Global, LLC GA
- Boston Scientific Limited IE
Companies with recent recalls
- NOxBOX Limited 6 recall(s)
- Draeger, Inc. 7 recall(s)
- Boston Scientific Corporation 187 recall(s)
- ASP Global, LLC 3 recall(s)
- MIDMARK CORP. 4 recall(s)
- DEROYAL INDUSTRIES, INC. 47 recall(s)
- ICU MEDICAL, INC. 66 recall(s)
- Heraeus Medical GmbH 3 recall(s)
- SeaSpine Orthopedics Corporation 9 recall(s)
- Cardinal Health 200, LLC 68 recall(s)
- BAXTER HEALTHCARE CORPORATION 210 recall(s)
- PERCUSSIONAIRE CORP. 8 recall(s)