The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2236-2023·Announced 2023-08-02

Trexo Device recalled due to electrical hazards and burn risk

Trexo Robotics is recalling the Trexo Device due to electrical issues that could cause burns, device malfunction, and electromagnetic interference with other equipment. Consumers should stop using affected devices.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA medical device recall with electrical hazards and risk of burns during use. Although no injuries have been reported, the potential for harm to users justifies a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Trexo Device, manufactured by Trexo Robotics Holdings Inc., is being recalled worldwide due to electrical hazards affecting 357 units. The device may experience electrical issues that could render it non-functional, emit electromagnetic interference affecting surrounding equipment, or create a risk of burns during use.

The recall affects devices distributed worldwide, including throughout the United States and to 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. All units of the Trexo Device are subject to this recall.

Users of the Trexo Device should discontinue use immediately and contact Trexo Robotics Holdings Inc. for further instructions or replacement options. The FDA's Medical Devices division issued this Class II recall (FDA Z-2236-2023) to address these electrical safety hazards.

The recalled product

Product
Trexo Device
Manufacturer
Trexo Robotics Holdings Inc.
Category
Medical Device
Hazard
Affected units
357

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All devices.

Distribution

Distributed nationwide across the United States.

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