Medical device recalls Moderate risk

Trexo Robotics Holdings Inc. recalls Trexo Device

Recall date
May 31, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2236-2023
FDA classification
Class II
Brand / firm
Trexo Robotics Holdings Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of the Argentina, Australia, Brazil, Canada, China, Croatia, Czech Republic, England, Germany, India, Kuwait, Mexico, Poland, Qatar, Republic of Cyprus, Serbia, Singapore, Slovakia, Spain, United Arab Emirates, and Yemen.

Why it was recalled

Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Trexo Device

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