ReWalk Personal 6 — Class II medical device recall Z-1553-2021
Terminated recall by Argo Medical Technologies Ltd, reported 2021-05-19, distributed nationwide. ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk dev
| Recall number | Z-1553-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argo Medical Technologies Ltd, Haifahaifa, Israel |
| Recall initiated | 2020-02-28 |
| Classified | 2021-05-11 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2021-11-10 |
| Distributed | Nationwide (US) |
| Quantity | 350 units |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1553-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.