Atalante X Exoskeleton (Wandercraft) – Balance Loss Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
WANDERCRAFT SAS
Lot Codes / Batch 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.
Products Sold
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.
WANDERCRAFT SAS is recalling Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobilit due to Potential for exoskeleton to lose lateral balance and cause patient to fall.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY, PA
Page updated: Jan 10, 2026