Z-2236-2023Class II

Trexo Device

Name: Z-2236-2023 Trexo Device
Creator: Trexo Robotics Holdings Inc.
Published: 2023-05-31
License: https://open.fda.gov/license/

Trexo Robotics Holdings Inc. / initiated 2023-05-31 / Open, Classified / root cause: design

FDA source

Trexo Robotics Holdings Inc. began a recall of Trexo Device on 2023-05-31. FDA classified it as Class II and gives the reason as "Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2236-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-31
Posted: 2023-07-25
Recalling firm: Trexo Robotics Holdings Inc.
Product: Trexo Device
Product code: IKK System, Isokinetic Testing And Evaluation
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 357 units
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.
Product codes and lots: All devices.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2236-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2236-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-25

Product code IKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)