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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.
2,805 device facilities and 1,175 companies with FDA recall history · data as of 2026-10-06
Latest FDA actions
- Warning letterChirp Innovation, LLC (opens in a new tab) Utah
- Inspection VAITrax Surgical, Inc. (opens in a new tab)
- Inspection VAIMaymom LLC (opens in a new tab)
- Inspection VAIHeartbeam (opens in a new tab)
- Inspection VAIRevolutionary Science (opens in a new tab)
- Inspection VAIVeritiv Operating Company (opens in a new tab)
- Inspection VAIOpus KSD, Inc. (opens in a new tab)
- Inspection VAIX-Ray Systems, Inc. dba X-Cel X-Ray Corporation (opens in a new tab)
- Warning letterO.N. Diagnostics, LLC (opens in a new tab) California
- Inspection VAIBeacon Bio Dx LLC (opens in a new tab)
- Inspection VAIEEG Software LLC (opens in a new tab)
- Inspection VAISMD Manufacturing, LLC (opens in a new tab)
- Warning letterPeter Schiff Enterprises (opens in a new tab) Tennessee
- Warning letterAdvance-Esthetic LLC · letter (opens in a new tab) Florida
- Class IBoston Scientific Corporation
- Warning letterPensar Medical (opens in a new tab) Texas
- Class IIPhilips North America Llc
- Class IIMIDMARK CORP.
- Class IIDEROYAL INDUSTRIES, INC.
- Class IIICU MEDICAL, INC.
- Class IIWilson-Cook Medical Inc.
- Warning letterNext Medical Products Company, LLC (opens in a new tab) New Jersey
- Class IIOlympus Corporation of the Americas
- Class IIOlympus Corporation of the Americas
- Class IISeaSpine Orthopedics Corporation
- Class IIStryker Sustainability Solutions
- Warning letterKoven Technology, Inc. · letter (opens in a new tab) Missouri
- Warning letterNipro Renal Solutions USA, Corporation · letter (opens in a new tab) Pennsylvania
- Warning letterSpecialty Health Products CO, LLC (opens in a new tab) Arizona
- Warning letterGentuity, LLC · letter (opens in a new tab) Massachusetts
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
- Boston Scientific Limited IE
- Boston Scientific Corporation CA
- BOSTON SCIENTIFIC CORPORATION MA
- Boston Scientific Corporation GA
- Boston Scientific Corporation CR
- Boston Scientific Corp., Marina Bay Cust. Fulfillment Center MA
- Boston Scientific Limited IE
- BOSTON SCIENTIFIC CORPORATION CR
- Boston Scientific Corporation RI
- Cryterion Medical Inc. CA
- BOSTON SCIENTIFIC CORPORATION IN
- Boston Scientific Corporation PR
Companies with recent recalls
- Boston Scientific Corporation 187 recall(s)
- MIDMARK CORP. 4 recall(s)
- DEROYAL INDUSTRIES, INC. 47 recall(s)
- ICU MEDICAL, INC. 66 recall(s)
- SeaSpine Orthopedics Corporation 9 recall(s)
- NOxBOX Limited 5 recall(s)
- BAXTER HEALTHCARE CORPORATION 210 recall(s)
- ABIOMED, INC. 31 recall(s)
- COOPERVISION, INC. 13 recall(s)
- COOPERSURGICAL, INC. 57 recall(s)
- Medline Industries, LP 237 recall(s)
- Becton, Dickinson and Company 2 recall(s)