CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report
Atalante X, Powered Exoskeleton recalled by Wandercraft Sas
Wandercraft SAS is recalling Atalante X, Powered Exoskeleton, distributed in New York, Pennsylvania. The recall was initiated on 3 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1739-2025
- FDA event ID
- 96635
- Recalling firm
- Wandercraft SAS, Paris, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Apr 2025
- FDA classified
- 8 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 3 Apr 2025 | Recall initiated by company | |
| 8 May 2025 | Classified by FDA | +35 days |
| 14 May 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Product as listed by the FDA
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.
Where it was distributed
Domestic: PA & NY.
Questions about this recall
Why was it recalled?
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Which lots are affected?
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.
Where was it sold?
Domestic: PA & NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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