FDA recall Z-2236-2023

Product

Trexo Device

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2023-05-31

Report date

2023-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mississauga, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2236-2023