Atalante X, Powered Exoskeleton recallZ-1739-2025 · Wandercraft Sas · initiated Apr 3, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Wandercraft Sas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for exoskeleton to lose lateral balance and cause patient to fall.
FDA root cause category: Use error
What the company is doing
An URGENT SAFETY NOTICE dated 4/3/25 was mailed to consignees. The letter notifies consignees that WANDERCRAFT will be reinforcing their training program for the Atalante X and providing additional instructions by 5/1/25. Until the additional instructions can be provided, users are being instructed to only have certified Atalante X operators maintain the stability of the exoskeleton at all times by keeping at least one hand on the handles throughout the session. Consignees are to share the recall notification with users at their facility and retained for awareness.
Recall details
- Recall number
- Z-1739-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 3, 2025
- Posted by the FDA
- May 8, 2025
- Recalling firm
- Wandercraft Sas
- Quantity
- 3
- Product code
- PHL
- FDA submissions
- K221859
- Distribution
- Domestic: PA & NY.
Product description
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.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Atalante X ATA-002-EN USWandercraft · Powered Exoskeleton1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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