FDA Device recall Z-1739-2025
Atalante X, Powered Exoskeleton
- FDA Device
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of Atalante X, Powered Exoskeleton by Wandercraft Sas, citing potential for exoskeleton to lose lateral balance and cause patient to fall.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1739-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-03 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Wandercraft Sas |
| Distribution | NY, PA |
Product
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
Reason
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Identifiers
| code_info | UDI: (01)3665965000129(21)V5_ABP(11)AA06JJ, (01)3665965000129(21)V5_ACH(11)AA09JJ, (01)3665965000129(21)V5_ADO(11)AA02JJ. No model or serial number. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1739-2025%22
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