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.
2,845 device facilities and 1,177 companies with FDA recall history · data as of 2026-09-07
Recently updated facilities
- IMRIS Imaging, Inc. MN
- Merge Healthcare Incorporated WI
- Merge Canada CA
- FUJIFILM Healthcare Americas Corporation MA
- SDI LTD. AU
- MIDMARK CORPORATION OH
- PARAGONIX TECHNOLOGIES, INC. MA
- MIDMARK CORP. OH
- BECKMAN COULTER, INC. FL
- BECKMAN COULTER, INC. CA
- BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. CN
- BECKMAN COULTER, INC. FL
Companies with recent recalls
- IMRIS Imaging, Inc. 2 recall(s)
- Merge Healthcare 84 recall(s)
- FUJIFILM Healthcare Americas Corporation 12 recall(s)
- SDI LTD. 1 recall(s)
- MIDMARK CORP. 3 recall(s)
- Paragonix Technologies 1 recall(s)
- BECKMAN COULTER, INC. 216 recall(s)
- BMC Medical Co., Ltd 1 recall(s)
- Boston Scientific Corporation 184 recall(s)
- Cardinal Health 200, LLC 65 recall(s)
- CONMED CORPORATION 24 recall(s)
- Medline Industries, LP 230 recall(s)
Recent FDA warning letters
- O.N. Diagnostics, LLC (opens in a new tab) California · 2026-09-01
- Advance-Esthetic LLC · letter (opens in a new tab) Florida · 2026-08-25
- Pensar Medical (opens in a new tab) Texas · 2026-08-21
- Next Medical Products Company, LLC (opens in a new tab) New Jersey · 2026-08-19
- Koven Technology, Inc. · letter (opens in a new tab) Missouri · 2026-07-21
- Nipro Renal Solutions USA, Corporation · letter (opens in a new tab) Pennsylvania · 2026-07-16
- Specialty Health Products CO, LLC (opens in a new tab) Arizona · 2026-07-07
- Gentuity, LLC · letter (opens in a new tab) Massachusetts · 2026-07-02
- Happiest Baby, Inc · letter (opens in a new tab) California · 2026-06-15
- Nihon Kohden Digital Health Solutions, LLC. · letter (opens in a new tab) California · 2026-06-15
Letter links open an FDA search; FDA can take several weeks to post a letter, so a very recent one may not appear there yet.
Recent FDA inspections (OAI/VAI)
- Starch Medical Inc. (opens in a new tab) VAI · 2026-08-26
- Retropsoas Technologies LLC (opens in a new tab) VAI · 2026-08-26
- Westec Plastic Corporation (opens in a new tab) VAI · 2026-08-24
- Cetro America Inc. (opens in a new tab) VAI · 2026-08-21
- Blueroot Health, Inc. (opens in a new tab) VAI · 2026-08-19
- Hemedex, Inc. (opens in a new tab) VAI · 2026-08-19
- ECLOSION (opens in a new tab) VAI · 2026-08-13
- CRYON-X LLC (opens in a new tab) VAI · 2026-08-12
- Angstrom Manufacturing, Inc. (opens in a new tab) VAI · 2026-08-12
- Enterix, Inc. (opens in a new tab) VAI · 2026-08-10
Inspection links open the FDA Data Dashboard profile for that firm, which can take several seconds to load.
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