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Incident · Recall

FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk

ReWalk Robotics initiated a Class 2 device recall on February 28, 2020, after receiving two complaints (one in the US, one in Germany) alleging that the ReWalk device waistpack containing Li-Ion battery packs caught fire while being charged. The recall affected 350 units distributed nationwide in the US. The FDA determined the cause as device design. The recall was terminated on November 10, 2021.

Occurred 2020-02-28 · ReWalk Personal Exoskeleton at Multiple, USA · ReWalk Robotics · Multiple, USA · Exoskeletons · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk

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Sources (1)

  1. FDA · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=187111 · 2021-05-11

Status history

  • Active · 2026-08-11 · agent:recon

Common questions

What happened in FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk?
ReWalk Robotics initiated a Class 2 device recall on February 28, 2020, after receiving two complaints (one in the US, one in Germany) alleging that the ReWalk device waistpack containing Li-Ion battery packs caught fire while being charged. The recall affected 350 units distributed nationwide in the US. The FDA determined the cause as device design. The recall was terminated on November 10, 2021.
When did this incident occur?
The incident is recorded as occurring on February 28, 2020 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk?
ReWalk Personal Exoskeleton by ReWalk Robotics is the recorded robot involved in this incident at Multiple, USA.
Has anyone responded to FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-23

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-23

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk.

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Canonical ID 272fb246-7955-4802-83c4-5d54b0871110