Argo Medical Technologies Ltd: Medical Device Recall in 2021 - (Recall #: Z-1553-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.

Product Classification:

Class II

Date Initiated: February 28, 2020

Date Posted: May 19, 2021

Recall Number: Z-1553-2021

Event ID: 87818

Reason for Recall:

ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged.

Status: Terminated

Product Quantity: 350 units

Code Information:

All Serial numbers

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated