FDA Medical devices recall ·
Atalante X, Powered Exoskeleton recall
- Recall number
- Z-1739-2025
- Date
- (initiated April 3, 2025)
- Company / brand
- Wandercraft Sas
88 Rue De Rivoli, Paris, N/A, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3
- Hazard tags
- Fall
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for exoskeleton to lose lateral balance and cause patient to fall.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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.
Distribution
Domestic: PA & NY.
States: New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1739-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.