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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Atalante X Powered Exoskeleton Recalled for Fall and Balance Risk

Agency Publication Date: May 8, 2025
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Summary

Wandercraft SAS is recalling three units of the Atalante X Powered Exoskeleton used in rehabilitation institutions for mobility exercises. The device may lose its side-to-side (lateral) balance, which could cause a patient to fall during use. No injuries have been reported to date, and the manufacturer is initiating this voluntary recall to prevent potential accidents.

Risk

The exoskeleton can lose its lateral balance while a patient is performing ambulatory or mobility exercises. This failure poses a serious fall risk to patients, even when they are under the supervision of a trained operator in a clinical setting.

What You Should Do

  1. This recall affects three units of the Atalante X Powered Exoskeleton identified by Unique Device Identifier (UDI) codes (01)3665965000129(21)V5_ABP(11)AA06JJ, (01)3665965000129(21)V5_ACH(11)AA09JJ, and (01)3665965000129(21)V5_ADO(11)AA02JJ.
  2. Stop using the recalled device immediately. Contact Wandercraft SAS or your distributor to arrange for the return, replacement, or correction of the equipment.
  3. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Atalante X Powered Exoskeleton
UDI:
(01)3665965000129(21)V5_ABP(11)AA06JJ
(01)3665965000129(21)V5_ACH(11)AA09JJ
(01)3665965000129(21)V5_ADO(11)AA02JJ

Intended for ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator. No model or serial numbers provided.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96635
Status: Active
Manufacturer: WANDERCRAFT SAS
Sold By: rehabilitation institutions
Manufactured In: France
Units Affected: 3
Distributed To: Pennsylvania, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.