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Open, Classified

Trexo Device

FDA Recall Z-2236-2023 · Posted 2023-07-25

Recall StatusOpen, Classified
Product CodeIKK
Date Initiated2023-05-31
Product Quantity357 units

Reason for Recall

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

Firm Action

The firm distributed recall notification to customers by email on 5/31/2023. This notification asks that customers not expose the device to rain or spilled liquids, not store the device outdoors, wear pants to cover exposed skin to minimize the effect of hot surfaces, and if experiencing any electrical interference or difficulty operating another device in the vicinity of a Trexo device move away and and/or turn off the Trexo Device. Affected devices will be subject to a correction which will be carried out by technician; technician appointments will be scheduled once customers reply to the recall notification. Customers with any questions or concerns may contact the firm at [email protected]. Customers are asked to return the provided response form.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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