Summary
The FDA issued a Class II for Trexo Device by Trexo Robotics Holdings Inc.. Reason: Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of bu.
Details
Source
Device Recall
External ID
Z-2236-2023
Action Date
2023-08-02
Status
Ongoing
Category
device
Product Description
Trexo Device
Lot/Code Info: All devices.
Quantity Affected: 357 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-31
Company
Mississauga, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Trexo Robotics Holdings Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Trexo Robotics Holdings Inc. have FDA actions?
This is the only FDA action we have on record for Trexo Robotics Holdings Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2236-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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